FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2202081
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03872
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. THE BATTERY DEPLETION WAS FOUND TO BE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS PREMATURELY AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE LEFT VENTRICULAR LEAD EXHIBITED CHRONIC HIGH THRESHOLDS AND AS SUCH, THE DEVICE HAD BEEN PROGRAMMED FOR HIGH OUTPUT DUE TO PHYSIOLOGICAL NEED. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 3830 X2 IMPLANTABLE PACING LEADS |