FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL
MDR report key: 2042226
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01314
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 18, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INFORMATION SUGGESTS BOTH THE LEAD AND CRT-D REMAINS IN SERVICE. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THIS PATIENT WAS USING A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT THE THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT) DETECTED NOISE. THE NOISE WAS OVERSENSED AND AS A RESULT PACING INHIBITION GREATER THAN 2 SECONDS WAS NOTED. THIS PATIENT DID HAVE A SLOW UNDERLYING RHYTHM WHICH NEGATED COMPLETE INHIBITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES DISCUSSED RECOMMENDATIONS OF SUCH UNITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | 0185| T167| H170| 4555| 4470 |