FDA Adverse Event
Injury
Summary report: N
ZEPHYR XL DR
MDR report key: 2240061
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05922
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 8, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- 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
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
(B)(6) 2011. FINAL ANALYSIS FOUND THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE BATTERY WAS PREMATURELY DEPLETED DUE TO HIGH CURRENT DRAIN. THE HYBRID WAS REMOVED FOR FURTHER ANALYSIS AND TESTED NORMAL. THE FAILURE MODE COULD NOT BE DUPLICATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. 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 | 5820 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |