FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 2962831
·
Received February 14, 2013
Report
- Report Number
- 2938836-2013-00128
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- December 29, 2012
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENTS OF NOISE AND AN IMPEDANCE ANOMALY WERE CONFIRMED IN THE LABORATORY. IT IS BELIEVED THAT THE ROOT CAUSE IS A POOR CONNECTION BETWEEN A COMPONENT AND THE SUBSTRATE.
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 PATIENT REPORTED TO THE HOSPITAL AFTER RECEIVING A VIBRATORY ALERT. INTERROGATION SHOWED NOISE AND LOW HIGH VOLTAGE IMPEDANCE. ICD WAS EXPLANTED AND REPLACED. WHEN LEADS WERE RECONNECTED TO THE NEW ICD, ALL MEASUREMENTS WERE NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64458 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |