FDA Adverse Event
Death
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
MDR report key: 3080258
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00995
- Event Type
- Death
- Date Received
- April 26, 2013
- Date of Event
- August 19, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 PATIENT EXPIRED DUE TO SEPTIC SHOCK. ICD POCKET EROSION WAS OBSERVED THEREFORE, ICD SYSTEM WAS EXPLANTED. THE PHYSICIAN BELIEVES THE IMPLANTED ICD SYSTEM POTENTIALLY CAUSED THE SEPSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180955 | DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7172Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | (B)(4) |