FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D, DF4 CONNECTOR
MDR report key: 3210623
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03432
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 11, 2013
- 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
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF PROGRAMMER PRINTOUTS. THE DEVICE WAS TESTED ON THE BENCH USING A KNOWN GOOD SET OF CAPACITORS AND CHARGING TIME WAS NORMAL. THE ORIGINAL HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE AND AN ANOMALY WAS FOUND. THE CAUSE OF THE EXTENDED CHARGE TIME WAS DUE TO AN HV CAPACITOR ANOMALY.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A VIBRATORY NOTIFIER FOR A LONG CHARGE TIME. NORMAL CHARGE TIMES WERE SEEN IN-CLINIC. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO EXTENDED CHARGE TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311724 | UNIFY CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3231-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |