FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4130830
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16201
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- August 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE THERAPIES DUE TO OVERSENSING. DURING LEAD REVISION, LEAD DISLODGEMENT WAS OBSERVED. TWIDDLER SYNDROME WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607647 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |