FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY AFX
MDR report key: 2240240
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05881
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- July 28, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN BACKUP VVI. REVIEW OF THE DEVICE MEMORY REVEALED -00- FOR CELL IMPEDANCE VALUES. THE BATTERY DATA ON (B)(6) 2011 WAS 2.74 V, 8 UA AND 4.7 KOHMS. DEVICE REPLACEMENT WAS PLANNED. THE PATIENT WAS PACEMAKER DEPENDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY AFX | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5346 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |