FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4173919
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16730
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 30, 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
- CA, US
- 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 OVERSENSING DUE TO NOISE WAS OBSERVED. THE NOISE COULD NOT BE REPRODUCED IN-CLINIC. PROGRAMMING CHANGES WERE MADE. NO PATIENT SYMPTOMS WERE REPORTED. THE LEAD REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THE PATIENT RECEIVED A PATIENT NOTIFIER DUE TO OVERSENSING NOISE. HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. NOISE WAS NOT REPRODUCIBLE. THE PATIENT CONDITION IS STABLE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATED THAT THE LEAD WAS CAPPED AND REPLACED. LEAD FRACTURE WAS NOTED. THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655847 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |