FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2791322
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05526
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) WITH LONGEVITY OF 3 AND A HALF YEARS. EARLY BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R | IEXCH151555 IMPLANTABLE STENT GRAFT| ILXCH161685 IMPLANTABLE STENT GRAFT| 6944 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| ENLW1616C82E IMPLANTABLE STENT GRAFT| ENLW1616C124E IMPLANTABLE STENT GRAFT| 5554 IMPLANTABLE PACING LEAD| ENBF3616C166E IMPLANTABLE STENT GRAFT |