FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX VDR
MDR report key: 3925927
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15705
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- May 16, 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 Occupation
- OTHER
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 PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE HAD REACHED A HARDWARE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403149 | IDENTITY ADX VDR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5480 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |