FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3872937
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11835
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- April 4, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
ADDITIONAL INFORMATION THAT THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING GREAT. THERE WAS NO ALLEGATION OF ELECTRICAL ANOMALIES AGAINST LEAD, JUST THAT IT WAS POSITIONED IN NON CONDUCTIVE TISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A NORMAL FOLLOW-UP HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE WAS NOTED. THE IMPEDANCE HAD BEEN GRADUALLY RISING. CAPTURE THRESHOLD WAS ALSO NOTED TO HAVE INCREASED SLIGHTLY. PATIENT IS NOT PACEMAKER DEPENDENT. THE LEAD WILL BE MONITORED. PATIENT CONDITION WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349499 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 7120Q/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |