FDA Adverse Event
Malfunction
Summary report: N
ACTIVA RC
MDR report key: 2244033
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06771
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 8, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING A LOT OF PAIN IN HER RIGHT LEG. IMPEDANCE TESTING SHOWED SOMEWHAT HIGH IMPEDANCES ON CONTACT 0 AND HIGH IMPEDANCES ON CONTACT 3. THOSE CONTACTS WERE NOT USED IN THE ACTIVE GROUP, AND IT WASN'T THOUGHT THAT THE LEG PAIN WAS RELATED TO THE DEVICE. 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 RC | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37612 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| EXPLANTED:| ADAPTER: MODEL 64002, LOT# N219879| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU010902V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0206635V| PROGRAMMER: MODEL 7436, LOT# NFU003862P| ACCESSORY: MODEL 37651, LOT# NKA138686N| EXPLANTED:| LEAD: MODEL 3387, LOT# J0206635V| EXTENSION: MODEL 7482, LOT# NHU010888V| IMPLANTED:| IMPLANTED:| EXPLANTED: |