FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 2014078
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01736
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- February 24, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- Z2977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR WAS IN BACKUP MODE. THE PRODUCT CODE COULD NOT BE DOWNLOADED AND MEASURED BATTERY DATA WAS LOST AT 2.32 V. THIS WAS CAUSED BY A DISCREPANT INTEGRATED CIRCUIT.
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 PULSE GENERATOR WAS INTERROGATED SEVERAL TIMES BUT MEASURED DATA COULD NOT BE READ. AFTER CHANGING TO VVI MODE, MEASURE DATA WAS OBSERVED. THE DEVICE HAD A MAGNET RATE OF 89 BPM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |