FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY SR
MDR report key: 1073323
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02117
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- 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 - FINAL ANALYSIS FOUND THAT THE DEVICE HAD NO OUT- PUT. THE PACEMAKER CAN AND INTEGRATED CIRCUIT (IC) PIN WERE BURNED, INDICATING THAT THE PACER HAD BEEN EXPOSED TO ELECTROCAUTERY, DEFIBRILLATION OR OTHER EXTERNAL ENERGY SOURCE SPECIFICALLY CAUTIONED AGAINST IN THE PHYSICIAN'S MANUAL. RELIABILITY LABORATORY TECHNICIAN, - NOT APPLICABLE - ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY - NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5142 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |