FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3791152
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10503
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- February 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT FELT FURTHER THUMPING. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY, AND THE LEAD REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST-IMPLANT, THE PATIENT HAD INTERMITTENT DIAPHRAGMATIC STIMULATION. IT WAS NOTED THAT THE PATIENT FELT THUMPING ON THEIR SIDE AND FULLNESS IN THEIR THROAT. THE DEVICE WAS REPROGRAMMED MULTIPLE TIMES. THUMPING WAS STILL NOTICEABLE. THE LEAD WAS SUCCESSFULLY REPOSITIONED AND THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269281 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |