FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2952485
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01736
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCTS: 4193, IMPLANTABLE PACING LEAD - (B)(6) 2007; 1688T, COMPETITOR IMPLANTABLE PACING LEAD - (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT THE DEVICE 'DIDN'T LAST EVEN THREE YEARS.' THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56090 | 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 | 00081 YR | Hospitalization| R | 0125 COMPETITOR IMPLANTABLE TACHY LEAD |