FDA Adverse Event
Malfunction
Summary report: N
VERITY ADX XL
MDR report key: 3920719
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14313
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- April 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
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 DURING A LEAD REPOSITIONING PROCEDURE, THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT AND THE PATIENT WENT ASYSTOLIC. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396349 | VERITY ADX XL | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5056 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | (B)(4) |