FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2203156
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04311
- 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
- MA, 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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MET EXPECTED LONGEVITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD EARLY ERI (ELECTIVE REPLACEMENT INDICATOR), AND THAT THERE WAS HIGH LV (LEFT VENTRICULAR) THRESHOLD . THE DEVICE AND LEFT VENTRICULAR LEAD WERE REMOVED 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 | 80 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |