FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION LEAD
MDR report key: 3890368
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03630
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- October 26, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 OT THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENT TO CLINIC AFTER RECEIVING A PATIENT NOTIFIER. UPON INTERROGATION, HIGH LEAD IMPEDANCE WAS OBSERVED. FURTHER INTERROGATION SHOWS THAT THE SET SCREW HAD NOT BEEN TIGHTEN PROPERLY AT IMPLANT. THE SET SCREW WAS PROPERLY TIGHTENED AND LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30325 | DURATA STS OPTIM ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL INC., CRMD | 7121-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |