FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION
MDR report key: 3911093
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-13059
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- May 23, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING AND LEAD NOISE THAT WERE DETECTED AS VF EPISODES. X-RAY DID NOT REVEAL ANY LEAD ANOMALIES. NO NOISE OR IMPEDANCE CHANGES WERE OBSERVED DURING ARM MOVEMENT OR POCKET MANIPULATION. THE PHYSICIAN REPROGRAMMED THE DEVICE AS RECOMMENDED. THE PATIENT WAS STABLE AND DISCHARGED HOME AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385796 | DURATA STS OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 2207-36, 527346 |