FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION
MDR report key: 3781840
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-09942
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- March 26, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
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 DURING A FOLLOW UP, AN INCREASE IN PACING LEAD IMPEDANCE AND CAPTURE THRESHOLD WERE OBSERVED. DURING A DEVICE CHANGE OUT DUE TO ERI, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. DEFIB PORTION REMAINS ACTIVE. THERE WERE NO COMPLICATIONS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258842 | DURATA STS OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |