FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4021879
·
Received August 19, 2014
Report
- Report Number
- 2938836-2014-14453
- Event Type
- Injury
- Date Received
- August 19, 2014
- Date of Event
- July 12, 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 Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW-UP, NON-SUSTAINED VENTRICULAR OVERSENSING WAS OBSERVED. NO PATIENT SYMPTOMS WERE REPORTED. REVIEW OF THE EGMS REVEALED POSSIBLE LEAD NOISE. NOISE COULD NOT BE REPLICATED WITH PROVOCATIVE TESTING. LEAD IMAGING WAS RECOMMENDED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE. THE PATIENT DID WELL DURING AND AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497811 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |