FDA Adverse Event
Injury
Summary report: N
EPIC PLUS HF CRT-D
MDR report key: 4130794
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16195
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- September 22, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- 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 THE 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 DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT WAS FINE AFTER THE EVENT AND HAD NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607634 | EPIC PLUS HF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | V-350 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |