FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3791166
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10534
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- March 4, 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
- AU
- 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 THE PATIENT CAME IN FOR A ROUTINE DEVICE CHECK AND HIGH PACING LEAD IMPEDANCE WAS OBSERVED. MONITORING WILL CONTINUE. PATIENT WAS WELL AFTER THE EVENT.
Description of Event or Problem · 1
NEW INFORMATION THAT THE LEAD WAS CAPPED DUE TO OUT OF RANGE LEAD IMPEDANCE. TWIDDLER SYNDROME WAS NOTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268907 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | 1207-36, 674623 |