FDA Adverse Event
Injury
Summary report: N
UNIFY QUADRA CRT-D, DF4 CONNECTOR
MDR report key: 3210543
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03445
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 3, 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
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT PRESENTED IN THE HOSPITAL AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPIES. THE CAUSE OF THE INAPPROPRIATE THERAPIES WAS UNDERSENSING ON THE ATRIAL CHANNEL. PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310669 | UNIFY QUADRA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |