FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4130847
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16174
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- August 28, 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 A DECREASE IN SENSING WAS OBSERVED. DISLODGEMENT WAS SEEN VIA X-RAY. DURING REVISION, IT WAS NOTED THAT THE LEAD WAS NOT FIXED WITH THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED WHEN REPOSITIONING WAS UNSUCCESSFUL. THE PATIENT CONDITION AFTER THE EVENT WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608168 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |