FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 4687578
·
Received April 14, 2015
Report
- Report Number
- 3004209178-2015-07170
- Event Type
- Injury
- Date Received
- April 14, 2015
- Report Date
- April 6, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V030671, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT # V012262, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 7436, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SUFFERED A RIGHT LEAD FRACTURE THAT REQUIRED REPLACEMENT. REFER TO MANUFACTURING REPORT #3004209178-2015-04221 FOR THE PATIENT¿S CURRENT ISSUES WITH A SPACY SENSATION AND PROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246645 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |