FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD
MDR report key: 3891023
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03631
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 8, 2011
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION INCLUDED. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH IMPEDANCE DURING IMPLANT. THE LEAD WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25767 | DURATA STS OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD, LWS | LWS | ST. JUDE MEDICAL INC., CRMD | 7121/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |