FDA Adverse Event
Malfunction
Summary report: N
CONCERTO II CRT-D
MDR report key: 2811141
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06067
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING. 9 - VENTRICULAR NST<=200 MS BETWEEN (B)(6) 2012 10:56:50 AND (B)(6) 2012 17:22:00. 1- VF=190 MS AVERAGE V-CYCLE ON (B)(6) 2012 19:53:58.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS OVERSENSING. THE DEVICE REMAINS 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 II CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D274TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | 4087 COMPETITOR IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| 0185 COMPETITOR IMPLANTABLE TACHY LEAD |