FDA Adverse Event
Death
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2160354
·
Received July 13, 2011
Report
- Report Number
- 2647346-2011-00938
- Event Type
- Death
- Date Received
- July 13, 2011
- Date of Event
- June 3, 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
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 EXPIRED DUE TO A CARDIAC ARREST. THE EVENT WAS CAPTURED ON THE CARELINK MONITOR WHICH TRANSMITTED AN ALERT FOR "ALL THERAPIES EXHAUSTED" 3 HOURS AFTER THE EVENT DUE TO THE PHONE LINE BEING BUSY AT THE TIME THE EVENT OCCURRED. THE PATIENT RECEIVED 30 APPROPRIATE SHOCKS AND THE DEVICE FAILED TO SHOCK 14 TIMES BEFORE THE THERAPIES WERE EXHAUSTED.
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 | 43 YR | Death| L| O | 2490C PATIENT MONITORING INSTRUMENT |