FDA Adverse Event
Injury
Summary report: N
IDENTITY SR
MDR report key: 2014011
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01723
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 19, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND NO OUTPUT OR TELEMETRY DURING INTERROGATION. THE DEVICE WAS AT END-OF-LIFE (EOL) DUE TO NORMAL BATTERY DEPLETION. AFTER REPLACING THE BATTERY, NORMAL FUNCTION ENSUED.
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 TO THE HOSPITAL EXPERIENCING AN INTRINSIC HEART RATE IN THE 40'S. THE PULSE GENERATOR EXHIBITED NO MAGNET RATE AND COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5172 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |