FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 3872895
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11777
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- April 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AUTO MODE SWITCH EPISODES DUE TO OVERSENSING OF NOISE WERE OBSERVED VIA REMOTE TRANSMISSION. NO PATIENT SYMPTOMS WERE REPORTED. FURTHER EVALUATION WAS RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349670 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | (B)(4) |