FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4130805
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16242
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- August 20, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LEAD REVISION DUE TO DECREASED R-WAVE SENSING AMPLITUDES, LEAD DISLODGEMENT WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS FINE AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607467 | 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 | 1999/52, CWK032141 |