FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2954591
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-02457
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- July 19, 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT DEVICES: 7120 COMP. IMPLANTABLE TACHY LEAD (B)(6) 2011; 1258T COMP. IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
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 PATIENT'S DEVICE WAS EXPLANTED DUE TO INFECTION. ANOTHER DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONSWERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58132 | 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 | 5076 IMPLANTABLE PACING LEAD |