FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2945722
·
Received February 6, 2013
Report
- Report Number
- 3004209178-2013-01360
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 17, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V252498, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# J0306938V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND WARMTH AT THE BATTERY SITE. ANTIBIOTICS WERE ADMINISTERED; HOWEVER, INFECTION DID NOT EXIST AT THE TIME OF THE REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50219 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |