FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 2000475
·
Received February 15, 2011
Report
- Report Number
- 3006630150-2011-00184
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- January 21, 2010
- Report Date
- January 21, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEADS WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE THE PT WAS EXPERIENCING NUMBNESS AND DIFFICULTY COMMUNICATING. THE PT'S LEG ALSO STARTED TO JERK SO THE PHYSICIAN DECIDED TO EXPLANT THE LEADS. THE PT HAD INDICATED THAT HE WAS NOT VOLUNTARILY JERKING HIS LEG BUT RATHER THE MEDICATION THE PT WAS ON WAS CAUSING HIS LIMB TO JERK. THE PHYSICIAN ALSO BELIEVES THAT THE PT WAS TAKING AN UNK MEDICATION AT THE TIME OF THE PROCEDURE WHICH WAS THE CAUSE OF THE SEIZURE LIKE EPISODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014"| (B)(4)| STYLET (STREAMLINED): MODEL# SC-2218-50E, |