FDA Adverse Event
Injury
Summary report: N
CONCERTO CRT-D DR
MDR report key: 2964452
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02342
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- December 5, 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
- TX, 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. CONCOMITANT PRODUCTS: 4196 IMPLANTABLE PACING LEAD, (B)(6) 2009; 6935 IMPLANTABLE TACHY LEAD, (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S SON THAT THE PATIENT WAS "FEELING A JERK OR A SHOCK" LIKE "SOMETHING WAS HITTING [THE PATIENT] IN THE STOMACH." FOLLOW UP WITH THE PHYSICIAN WAS ATTEMPTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69084 | CONCERTO CRT-D DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | C154DWK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Life Threatening | 4076 IMPLANTABLE PACING LEAD |