FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS VR, DF-4 CONNECTOR
MDR report key: 3872909
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11775
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- April 10, 2014
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF AN INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. PREMATURE BATTERY DEPLETION WAS CAUSED BY HIGH CURRENT DRAW. THE HIGH CURRENT WAS LOST DURING TESTING. CAUSE OF HIGH CURRENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE DEVICE COULD NOT BE INTERROGATED. DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349168 | CURRENT PLUS VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |