FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 1596864
·
Received February 9, 2010
Report
- Report Number
- 6000144-2010-00425
- Event Type
- Injury
- Date Received
- February 9, 2010
- Date of Event
- December 18, 2009
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 1
IT WAS REPORTED THE BATTERY VOLTAGE WAS 2.55V. THE PATIENT ALERT HAD BEEN TRIPPED NINE MONTHS EARLIER, DUE TO CHARGE TIME GREATER THAN 16 SECONDS (22.5 SEC). A CHARGE CIRCUIT TIME OUT ON (B) (6) 2009, WAS ALSO NOTED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE 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 | 91 YR | Required Intervention | 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |