FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3791131
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10532
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- February 1, 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
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT INAPPROPRIATE ATP THERAPY DUE TO NOISE AND AN INCREASE IN PACING LEAD IMPEDANCE WAS OBSERVED. THE NOISE WAS NOT REPRODUCED WITH ISOMETRICS OR MANIPULATION. IT WAS SUSPECTED THAT THE NOISE WAS DUE TO EMI. THE LEAD WAS CLOSELY MONITORED. SEVERAL WEEKS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS DOING VERY WELL AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268412 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |