ACTIVA
Report
- Report Number
- 3004209178-2013-05850
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).
ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE HCP LEARNED OF THE EVENT, WHICH WAS AN INFECTION ON (B)(6) 2013. THE EXTENSION WAS EXPLANTED TWO DAYS LATER. IT WAS REPORTED THAT HOSPITALIZATION WAS REQUIRED, AND THE PATIENT EXPERIENCED AN ONGOING SERIOUS INJURY.
IT WAS REPORTED THAT THERE WAS EROSION AT THE LEAD-EXTENSION CONNECTION SITE. THE DEVICE WAS AT ERI, HOWEVER THE HCP WANTED TO WORK THROUGH THE EROSION ISSUES BEFORE REPLACING IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149439 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |