FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 3567491
·
Received January 10, 2014
Report
- Report Number
- 3004209178-2014-00480
- Event Type
- Injury
- Date Received
- January 10, 2014
- Report Date
- January 8, 2014
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID N EU_UNKNOWN_LEAD, SERIAL# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN; PRODUCT TYPE UNKNOWN PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT HAD A LEAD REVISION DONE IN (B)(6). THE REPORTER STATED, THE LEAD WAS REPLACED AND A NEW LEAD WAS PLACED FOR BETTER POSITION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18986 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |