FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 7706338
·
Received July 20, 2018
Report
- Report Number
- 3007566237-2018-02169
- Event Type
- Malfunction
- Date Received
- July 20, 2018
- Date of Event
- January 1, 2016
- Report Date
- October 5, 2018
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF MOVEMENT DISORDERS. IT WAS REPORTED HISTORICAL IMPEDANCES ON THE RIGHT SIDE FROM 2016 WERE: 84, 849, 1121, 846, 906, 1202, AND 937. HISTORICAL IMPEDANCES ON THE LEFT SIDE FROM 2016 WERE: 111, 1121, 1765, 1138, 1205, 914, 1265, 1072. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547945 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |