FDA Adverse Event
Injury
Summary report: N
PROTECTA CRT-D
MDR report key: 2812656
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06220
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- August 20, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S178
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) BECAUSE THE DEVICE DISCRIMINATOR FAILED TO DIFFERENTIATE THE SVT FROM VENTRICULAR FIBRILLATION (VF). THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTECTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D334TRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Life Threatening | 6947M IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD |