FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2951451
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01547
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 5, 2012
- Manufacturer
- MEDTRONIC
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. CONCOMITANT DEVICES: 4194 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO THE DEFIBRILLATOR DISCRIMINATOR NOT FILTERING OUT SUPRA VENTRICULAR TACHYCARDIA. THE DEFIBRILLATOR REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55429 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Life Threatening | 6932 IMPLANTABLE TACHY LEAD |