FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3884842
·
Received June 19, 2014
Report
- Report Number
- 2938836-2014-12146
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- May 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 DECREASED SENSE AMPLITUDE AND INCREASED CAPTURE THRESHOLD WERE NOTED. THE LEAD WAS OBSERVED TO BE DISLODGED DUE TO TWIDDLERS SYNDROME. THE LEAD WAS REPOSITIONED SUCCESSFULLY. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359848 | DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7172Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | (B)(4) |