FDA Adverse Event
Malfunction
Summary report: N
CONCERTO CRT-D DR
MDR report key: 1792291
·
Received August 10, 2010
Report
- Report Number
- 6000144-2010-03199
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S031
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT
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 BY THE PATIENT AND HOME HEALTH AIDE THAT THERE WAS "FEVER IN THERE", PAIN AT THE DEVICE AND INTO THE CHEST AND DOWN THE LEFT ARM INTERMITTENTLY. ADDITIONALLY, THE DISCOMFORT HAS REPORTEDLY BEEN ONGOING FOR APPROXIMATELY ONE MONTH AND INCLUDED SEVERAL FALLS. NO REDNESS OR SWELLING WAS NOTED PER THE HOME HEALTH AIDE. THE LONGEVITY OF THE DEVICE WAS ALSO QUESTIONED. THE PATIENT WAS DIRECTED TO THEIR PHYSICIAN. THERE ARE NO FURTHER COMPLAINTS OR CONCERNS NOTED. THE DEVICE REMAINS IMPLANTED AND IN USE.
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 | 75 YR | Required Intervention | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |