FDA Adverse Event
Injury
Summary report: N
IDENTITY SR
MDR report key: 1223023
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03237
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. WHEN THE TELEMETRY WAND WAS APPLIED, A -PLEASE LOCATE DEVICE- MESSAGE DISPLAYED. THE PATIENT WAS ASYMPTOMATIC WITH A PRESENTING RHYTHM OF 67 PULSES PER MINUTE. MAGNET APPLICATION DID NOT CHANGE THE PRESENTING RHYTHM. BATTERY DATA FROM ONE YEAR PRIOR WAS 2.71 V, 14 UA, AND 4.9 K, WITH AN ESTIMATED REMAINING LONGEVITY OF 1.25 YEARS. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5172 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |