FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-D
MDR report key: 2811233
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06308
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 THAT THE DEVICE WITHHELD DETECTION AND THERAPY DURING VENTRICULAR TACHYCARDIA (VT) EPISODE FOR A PERIOD OF TIME DURING TWO EPISODES. IT WAS ALSO REPORTED THAT EVENTUALLY THE DEVICE DELIVERED TREATMENT. THEREFORE THE ONSET FEATURE WAS TURNED OFF. IT WAS LATER REPORTED THAT THE TACHY SENSE (TS) INTERVAL OF ONE OF THE EPISODES DID NOT GET RESET DUE TO THE ONSET. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLD. THE DEVICE AND RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |