FDA Adverse Event
Malfunction
Summary report: N
VICTORY XL DR
MDR report key: 4200339
·
Received October 24, 2014
Report
- Report Number
- 2017865-2014-17638
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 2, 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
- CT, US
- 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 SCHEDULED REPLACEMENT PROCEDURE FOR AN ELECTIVE REPLACEMENT INDICATOR, THE PULSE GENERATOR WENT INTO BACKUP VVI MODE AND LOST VENTRICULAR OUTPUT. EXPOSURE TO ELECTROCAUTERY WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED AS SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679883 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | (B)(4) |