PRECISION®
Report
- Report Number
- 3006630150-2013-00520
- Event Type
- Injury
- Date Received
- March 26, 2013
- Date of Event
- February 28, 2013
- Report Date
- February 28, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD BEEN ABLE TO REGAIN MOST OF HER STRENGTH IN BOTH ARMS AND LEGS. THE PATIENT'S LEFT-SIDED ARM AND LEG HAD SENSITIVITY TO TOUCH WHILE THE RIGHT LEG HAD SLIGHT DEFICIENCIES SUCH AS OCCASIONAL FOOT DROP AND MINOR BALANCE ISSUES. THE PHYSICIAN FELT THAT THE PATIENT HAD IMPROVED SIGNIFICANTLY. THE PATIENT IS NOW WALKING UNASSISTED WITH NO CHAIR OR CANE AND WILL CONTINUE THE PHYSICAL THERAPY. AN EXPLANT PROCEDURE WILL BE PERFORMED PER THE PATIENT'S REQUEST.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING LEG WEAKNESS. THE PHYSICIAN CONFIRMED THAT THE EVENT WAS NOT DEVICE RELATED. THE PATIENT HAS MADE SMALL IMPROVEMENTS AND IS STILL UNDERGOING PHYSICAL THERAPY.
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD DECREASED MOTOR FUNCTION ON HER UPPER EXTREMITIES. THE PHYSICIAN EXPLORED THE SURGICAL AREA AND DID NOT FIND ANY HEMATOMA SO THE PHYSICIAN DECIDED TO CLOSE THE SURGERY AND MONITORED THE PATIENT. WHEN THE PATIENT WOKE UP, SHE REPORTED THAT SHE COULD NOT MOVE HER ARM. THE PATIENT WAS SENT FOR CT SCAN WITH AN INCONCLUSIVE RESULT, IN WHICH LEAD EXPLANT WAS DONE TO MINIMIZE POTENTIAL SPINAL CORD COMPRESSION. THE PATIENT REGAINED SOME MOTOR FUNCTION IN HER UPPER EXTREMITY AND WILL UNDERGO THERAPY AND REHABILITATION. IT WAS NOT SURE IF THE ISSUE WAS DEVICE RELATED OR NOT BUT THE DEVICE MIGHT HAVE CAUSED THE ISSUE.
A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD DECREASED MOTOR FUNCTION ON HER UPPER EXTREMITIES. THE PHYSICIAN EXPLORED THE SURGICAL AREA AND DID NOT FIND ANY HEMATOMA SO THE PHYSICIAN DECIDED TO CLOSE THE SURGERY AND MONITORED THE PATIENT. WHEN THE PATIENT WOKE UP, SHE REPORTED THAT SHE COULD NOT MOVE HER ARM. THE PATIENT WAS SENT FOR CT SCAN WITH AN INCONCLUSIVE RESULT, IN WHICH LEAD EXPLANT WAS DONE TO MINIMIZE POTENTIAL SPINAL CORD COMPRESSION. THE PATIENT REGAINED SOME MOTOR FUNCTION IN HER UPPER EXTREMITY AND WILL UNDERGO THERAPY AND REHABILITATION. IT WAS NOT SURE IF THE ISSUE WAS DEVICE RELATED OR NOT BUT THE DEVICE MIGHT HAVE CAUSED THE ISSUE.
A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD DECREASED MOTOR FUNCTION ON HER UPPER EXTREMITIES. THE PHYSICIAN EXPLORED THE SURGICAL AREA AND DID NOT FIND ANY HEMATOMA SO THE PHYSICIAN DECIDED TO CLOSE THE SURGERY AND MONITORED THE PATIENT. WHEN THE PATIENT WOKE UP, SHE REPORTED THAT SHE COULD NOT MOVE HER ARM. THE PATIENT WAS SENT FOR CT SCAN WITH AN INCONCLUSIVE RESULT, IN WHICH LEAD EXPLANT WAS DONE TO MINIMIZE POTENTIAL SPINAL CORD COMPRESSION. THE PATIENT REGAINED SOME MOTOR FUNCTION IN HER UPPER EXTREMITY AND WILL UNDERGO THERAPY AND REHABILITATION. IT WAS NOT SURE IF THE ISSUE WAS DEVICE RELATED OR NOT BUT THE DEVICE MIGHT HAVE CAUSED THE ISSUE.
A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD DECREASED MOTOR FUNCTION ON HER UPPER EXTREMITIES. THE PHYSICIAN EXPLORED THE SURGICAL AREA AND DID NOT FIND ANY HEMATOMA SO THE PHYSICIAN DECIDED TO CLOSE THE SURGERY AND MONITORED THE PATIENT. WHEN THE PATIENT WOKE UP, SHE REPORTED THAT SHE COULD NOT MOVE HER ARM. THE PATIENT WAS SENT FOR CT SCAN WITH AN INCONCLUSIVE RESULT, IN WHICH LEAD EXPLANT WAS DONE TO MINIMIZE POTENTIAL SPINAL CORD COMPRESSION. THE PATIENT REGAINED SOME MOTOR FUNCTION IN HER UPPER EXTREMITY AND WILL UNDERGO THERAPY AND REHABILITATION. IT WAS NOT SURE IF THE ISSUE WAS DEVICE RELATED OR NOT BUT THE DEVICE MIGHT HAVE CAUSED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123775 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |