FDA Adverse Event
Malfunction
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2201734
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03802
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 13, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN UNEXPECTED SHOCK FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ONE OF THE TREATMENT DISCRIMINATORS WITHHELD THERAPY FOR TWO CYCLES BEFORE TREATING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO CRT-D DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | C154DWK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Life Threatening| O | 5568 IMPLANTABLE PACING LEAD| T510-29H TISSUE VALVE| 5071 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |