FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY ADX DR
MDR report key: 3920430
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14038
- 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
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP. UPON ATTEMPTING TO INTERROGATE THE DEVICE, AN ERROR MESSAGE WAS DISPLAYED. NO FURTHER TROUBLESHOOTING WAS PERFORMED AS THE DEVICE WAS NEARING ELECTIVE REPLACEMENT FOR NORMAL BATTERY DEPLETION. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396726 | INTEGRITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |