FDA Adverse Event
Malfunction
Summary report: N
ACTIVA SC
MDR report key: 2153441
·
Received June 21, 2011
Report
- Report Number
- 3004209178-2011-04641
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 24, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A MEDICAL OR THERAPY PROBLEM WAS REPORTED. THE PATIENT EXPERIENCED BREAKTHROUGH TREMORS ON THE LEFT SIDE THAT LASTED 10-15 SECONDS. IT WAS A POSSIBLE FLUID SHORT. REPROGRAMMED AND AT 1 VOLT, PATIENT EXPERIENCED SHOCKING IN THE LEFT HAND WHICH MOVED INTO THE ARM. X-RAY IMAGING WAS REVIEWED. THE DEVICE DOES NOT CUT OUT AT REGULAR INTERVALS AND IT APPEARS TO BE RANDOM IN NATURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA SC | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37602 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | LEAD: MODEL 3389, LOT# J0349459V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37602| EXPLANTED:| IMPLANTED:| LOT# NFW140747H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU038321V| EXTENSION: MODEL 7482, LOT# NHU038320V| IMPLANTED:| LOT# NFW142168H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| LOT# NLA700567H| IMPLANTED:| LEAD: MODEL 3389, LOT# J0349458V| EXPLANTED: |