FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 2808267
·
Received October 29, 2012
Report
- Report Number
- 2017865-2012-09210
- Event Type
- Malfunction
- Date Received
- October 29, 2012
- Date of Event
- August 21, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT BOTH WIRE BONDS ON THE VB+ LIFTED. WITH THE BATTERY RECONNECTED TO THE PULSE GENERATOR IT EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS NOT PROVIDING ANY OUTPUT PACING TO THE PATIENT AND COULD NOT BE INTERROGATED. THE PATIENT HAD UNDERGONE SEVERAL EPISODES OF THERAPEUTIC RADIATION. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |