FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX XL DR
MDR report key: 3920403
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14041
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 23, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THE PULSE GENERATOR EXHIBITED A LOSS OF OUTPUT WHEN THE PHYSICIAN USED A PEAK PLASMA BLADE TO OPEN THE DEVICE POCKET. THE PATIENT HAD AN ESCAPE RHYTHM IN THE FIFTIES. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO OTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397404 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |