FDA Adverse Event
Malfunction
Summary report: N
VERITY ADX SR
MDR report key: 3923166
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14483
- Event Type
- Malfunction
- Date Received
- July 9, 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
- US
- Reporter Occupation
- NURSE
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 THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. AFTER A SOFTWARE DOWNLOAD, NORMAL FUNCTION RESUMED. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401916 | VERITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5156 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |