FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 3050904
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05918
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 13, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: 1688TC COMPETITOR IMPLANTABLE PACING LEAD 2013 (B)(6). 6947M IMPLANTABLE TACHY LEAD 2013 (B)(6).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED, THE DEVICE DID NOT HAVE ENOUGH JOULES TO DEFIBRILLATE THE PATIENT. THE DEVICE WAS EXPLANTED TWO DAYS POST IMPLANT AND A DEVICE WITH MORE JOULES WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148613 | CONSULTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D204TRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R | 4296 IMPLANTABLE PACING LEAD |