FDA Adverse Event
Malfunction
Summary report: N
EPIC DR
MDR report key: 3920891
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13325
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 12, 2006
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. ATTORNEY.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED THAT RESULTED IN NSVT. THE DEVICE WAS UNABLE TO BE INTERROGATED DUE TO A TELEMETRY DATA ERROR. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398278 | EPIC DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-235 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |