FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 3062212
·
Received April 16, 2013
Report
- Report Number
- 3004209178-2013-06400
- Event Type
- Injury
- Date Received
- April 16, 2013
- Report Date
- February 26, 2013
- 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
- NY, 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: 4196 IMPLANTABLE PACING LEAD 2010 (B)(6); 5076 IMPLANTABLE PACING LEAD 2010 (B)(6). (B)(4). PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS FOUND THE DEVICE HAD BATTERY DEPLETION WITH ELECTIVE REPLACEMENT INDICATOR DATE OF (B)(4) 2012.
Description of Event or Problem · 1
IT WAS REPORTED, THE DEVICE REACHED END OF SERVICE (EOS) AND THE LONGEVITY WAS UNEXPECTED. 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 |
|---|---|---|---|---|---|---|---|
| 163953 | 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 | 00064 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |