FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2964651
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02373
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- November 20, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 PRODUCT: 4193 IMPLANTABLE PACING LEAD: (B)(6) 2005. 5054 IMPLANTABLE PACING LEAD: (B)(6) 2004. 5076 IMPLANTABLE PACING LEAD: (B)96) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE LONGEVITY WAS SHORTER THAN EXPECTED DUE TO HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS ARE STILL 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 |
|---|---|---|---|---|---|---|---|
| 69302 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD |