FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1913492
·
Received November 12, 2010
Report
- Report Number
- 6000032-2010-09389
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 5, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD A COMPUTED AXIAL TOMOGRAPHY SCAN. HER IMPLANTABLE NEUROSTIMULATOR WAS NOT TURNED OFF DURING THE SCAN. DURING THE SCAN IT FELT LIKE HER BODY WAS BEING DEFIBRILLATED. ONCE THE SCAN STOPPED THE JOLTING ALSO STOPPED. AFTERWARD HER LEFT BODY SIDE WAS IN PAIN. SHE FELT VIBRATING WHEN SHE SLEPT ON THE SIDE WHERE THE IMPLANT WAS LOCATED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3986, LOT# NAM003925N| EXTENSION: MODEL 7496-66, LOT# YS0002451N| EXTENSION: MODEL 7496-66, LOT# YS0002476N| LEAD: MODEL 3986, LOT# NAM003926N| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: |