FDA Adverse Event
Injury
Summary report: N
ACTIVA RC
MDR report key: 2153219
·
Received June 28, 2011
Report
- Report Number
- 3004209178-2011-04901
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 31, 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION WITH PATIENT PROGRAMMER (WITH OR WITHOUT ANTENNA). THE PATIENT WAS NOT ABLE TO REGAIN THERAPEUTIC EFFECT FROM THEIR DEVICE. THE DYSTONIA SYMPTOMS CAME BACK BECAUSE OF LACK OF THERAPY. THE BATTERY DEPLETED AFTER THE PATIENT WALKED CLOSE TO A METAL DETECTOR. THIS WAS NORMAL BATTERY DEPLETION AND WAS WHY THE PROGRAMMER WOULD NOT WORK. THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED AND THE CURRENT PATIENT STATUS FOLLOWING REPLACEMENT WAS GOOD.
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 | 15 YR | Required Intervention | EXTENSION: MODEL 37085, LOT# NKN012528V| EXPLANTED:| LEAD: MODEL 3387S, LOT# V071747| IMPLANTED:| LEAD: MODEL 3387S, LOT# V082506| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ107250N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012526V| STIM ACCESSORY: MODEL 37092, LOT# 219520001| IMPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA144891N |