FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3173686
·
Received June 17, 2013
Report
- Report Number
- 9614453-2013-01440
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Report Date
- May 28, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS AT A STORE PUSHING A SHOPPING CART WHEN SHE STARTED ¿GETTING SHOCKS¿ IN HER RIGHT HAND. IT WAS NOTED THAT THE SHOCK TRAVELED UP HER RIGHT HAND. IT WAS FURTHER NOTED THAT "SOMEONE MENTIONED TO THE PATIENT THAT THERE WERE MAGNETS IN THE WHEELS OF THE SHOPPING CARTS." IT WAS NOTED THAT THE SHOCK DID NOT RESEMBLE A STATIC ELECTRIC SHOCK AND THAT IT WAS ¿QUITE SUBSTANTIAL.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274498 | ACTIVA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |