FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2778465
·
Received October 9, 2012
Report
- Report Number
- 3004209178-2012-09046
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Report Date
- September 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- 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 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# V993984, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED STIMULATION WAS TURNED OFF. WHEN THE PATIENT PROGRAMMER WAS USED TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) ONE SIDE WAS TURNED "OFF". IT WAS NOTED THE PATIENT WORE A CARDIAC MONITOR. THE INS HAD BEEN PROGRAMMED TWICE SINCE IMPLANT. THERAPY DID NOT SEEM TO BE WORSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MDT PUERTO RICO OPERATIONS CO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |