FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1223898
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03402
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- June 25, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE DEVICE AS RECEIVED TO BE IN BACKUP VVI WITH NORMAL BACKUP CHARACTERISTICS. AFTER DOWNLOADING THE DEVICE SOFTWARE, NORMAL DEVICE FUNCTION ENSUED AND BACKUP VVI DID NOT RECUR. THE REASON FOR THE BACKUP VVI COULD NOT BE DETERMINED. THE REPORTED ERRONEOUS MEASURED DATA COULD NOT BE VERIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PULSE GENERATOR INTERROGATION, ERRONEOUS MEASURED DATA WAS EXHIBITED. PREMATURE BATTERY DEPLETION WAS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |