FDA Adverse Event
Injury
Summary report: N
FORTIFY ST VR, DF-4 CONNECTOR
MDR report key: 4130734
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16222
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- July 2, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH, AND NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607322 | FORTIFY ST VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention | 7170Q/58, BKM017035 |