FDA Adverse Event
Injury
Summary report: N
ENTITY DR
MDR report key: 1050636
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01288
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- August 28, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 IN 2007, THE MEASURED BATTERY DATA WAS 2.74 V, LESS THAN 1 KOHMS WITH A MAGNET RATE OF 97.2 PPM. FIVE MONTHS LATER, THE MEASURED BATTERY DATA WAS 2.61 V, LESS THAN 1 KOHMS WITH A MAGNET RATE OF 91.5 PPM. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5326 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |