Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration,
Department of Health and Human Services. It contains information on actions
taken in connection with agency Regulatory activities.
March 16, 2005
05-11
PRODUCT
a) Medtronic Marquis VR, model 7230 Single Chamber
Implantable Cardioverter Defibrillator (ICD)
devices are tiered therapy implantable arrhythmia
control devices, which provide automatic detection
of ventricular arrhythmias and delivery of user-
selected therapies for the detected arrhythmia.
Therapies are automatically delivered following
detection or can be initiated via programming by the
physician. These ICDs are multi-programmable and have
the capability of transmitting via telemetry the
programmed values, measured and collected data, and
event markers. Recall # Z-0597-05;
b) Medtronic Maximo VR, model 7232 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0598-05;
c) Medtronic Marquis DR, model 7274 Dual Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0599-05;
d) Medtronic InSync Marquis, model 7277 Dual Chamber
Implantable Cardioverter Defibrillator (ICD) with
Cardiac Resynchronization Therapy.
Recall # Z-0600-05;
e) Medtronic Maximo DR, model 7278 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0601-05;
f) Medtronic InSync III Marquis, model 7279 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0602-05;
g) Medtronic InSync III Protect, model 7285 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0603-05;
h) Medtronic InSync II Marquis, model 7289 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0604-05.
CODE
a) (Serial numbers listed include all affected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
7230B S-Series: PLW600001S - PLW600646S.
7230Cx H-Series: PKD100001H - PKD116584H,
PKD117397H, PKD117553H, PKD117735H, and PKD117741H.
R-Series: PKD200084R - PKD200536R, PKD600016R --
PKD600113R. S-Series: PKD600009S - PKD608391S.
7230E S-Series: PLY600001S - PLY600749S and
PLY600839S.
b) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series:
PRN800001A - PRN800024Q. S-series PRN600001S --
PRN602430S and PRN604401S - PRN604831S;
c) (Serial numbers listed include all afffected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
H-Series: PKC100001H - PKC138887H and PKC142234H.
R-series: PKC200320R - PKC200572R.
A-Series: PKC120001S - PKC120092S and PKC600001S --
PKC617090S.
d) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) H-Series: PLT100002H --
PLT100583H. S-Series: PLT600001S - PLT611901S;
e) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PRM800001Q --
PRM800123Q. S-Series: PRM600001S - PRM605919S and
PRM606025S - PRM606035S;
f) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PLU400002Q --
PLU400172Q and PLU800002Q - PLU800878Q.
S-Series: PLU600001S - PLU602739S and PLU800001S --
PLU800085S;
g) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for exact
serial numbers affected.) Q-Series: PPC800001Q --
PP800011Q. H-Series: PPC100002H - PPC100005H.
S-Series: PPC600001S - PPC600184S.
h) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) S-Series: PRJ600001 --
PRJ609639S and PRJ614813 - PRJ614815S.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter starting on February 10, 2005. Firm initiated recall is ongoing.
REASON
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
VOLUME OF PRODUCT IN COMMERCE
100,288 devices.
DISTRIBUTION
Nationwide and Internationally.
