FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 2409336
·
Received January 10, 2012
Report
- Report Number
- 2017865-2012-00656
- Event Type
- Injury
- Date Received
- January 10, 2012
- Date of Event
- November 8, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS FOUND AN ANOMALOUS COMPONENT, WITHIN THE HV CHARGING CIRCUITRY. THIS ANOMALY CAUSED THE INABILITY TO COMPLETE A HIGH VOLTAGE CHARGE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INTERROGATION, CAPACITOR CHARGE TIME LIMIT REACHED ON (B)(6) 2011. THE REP ATTEMPTED TO PERFORM A CAP MAINTENANCE TWICE IN CLINIC, BUT HAD TO REMOVE THE WAND FROM THE DEVICE BOTH TIMES TO STOP CHARGING AFTER 30S. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |