FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4173939
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16680
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 12, 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
- 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, DECREASED SENSING WAS OBSERVED. THE PHYSICIAN NOTED THIS WAS DUE TO A MYOCARDIAL INFARCT AT THE LOCATION OF THE LEAD TIP. THE PACE/SENSE PORTION WAS CAPPED AND REPLACED. DEFIB PORTION OF THE LEAD REMAINS ACTIVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654110 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |