PRECISION®
Report
- Report Number
- 3006630150-2014-01331
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONTINUES TO SHOW SIGNS OF NEUROLOGICAL DEFICIT ON THE LEFT LOWER LIMB AND PARTIAL NEUROLOGICAL DEFICIT ON THE LEFT UPPER LIMB. THE PATIENT WAS TRANSFERRED TO AN OUTSIDE FACILITY FOR REHABILITATION AND IS RECOVERING.
ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THE PATIENT'S SYMPTOMS WERE WEAKNESS ON THE LEFT SIDE AND DIFFICULTY URINATING. A CT SCAN SHOWED A PRESENCE OF A LEFT C3-D2 HYPERDENSITY WITH SUSPECTED EPIDURAL HEMATOMA. MRI OF THE SPINAL COLUMN CONFIRMED A PRESENCE OF A LEFT POSTERIOR-POSTEROLATERAL EPIDURAL HEMATOMA AT C3-D2 CAUSING COMPRESSION OF THE SPINAL CORD. THE PHYSICIAN PERFORMED AN EMERGENCY SPINAL DECOMPRESSION AND EVACUATED THE HEMATOMA. THE PATIENT UNDERWENT A LAMINATOMY AT T2-C5 AND THE LAMINAS WERE REMOVED. THE LAMINECTOMY WAS EXTENDED AT T3 TO THE END OF THE HEMATOMA AND A LEFT SIDE C3 + C4 HEMILAMINECTOMY WAS PERFORMED CRANIALLY. THE PHYSICIAN BELIEVES THE EVENT IS PROCEDURE RELATED. THE PATIENT CONTINUES TO SHOW SIGNS OF PARESIS AS A RESULT OF THE EVENT. THE EVENT IS RESOLVING AND THE PATIENT IS RECOVERING.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2016 THAT AN MRI OF THE SPINE CONFIRMED A PRESENCE OF A LEFT SIDED SPINAL CANAL HYPER-DENSITY SUSPECTED TO REPRESENT A CERVICAL EPIDURAL HEMATOMA. POST-OPERATIVELY THE PATIENT CONTINUED TO SHOW SIGNS OF LEFT UPPER AND LOWER EXTREMITY WEAKNESS AND SENSORY LOSS CONSISTENT WITH A SPINAL CORD INJURY.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM; MODEL #: SC-2218-70, SERIAL/LOT#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-3138-35, SERIAL/LOT#: (B)(4); DESCRIPTION: SCS PHIII EXT 35CM. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN AS THEY WERE 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 TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER, THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE PATIENT ALSO UNDERWENT A CERVICAL LAMINECTOMY AND CORD DECOMPRESSION. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
A REPORT WAS RECEIVED THAT DURING A TRIAL PROCEDURE WHEN THE LEADS WERE IMPLANTED SUCCESSFULLY AND THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR COMPLICATIONS. HOWEVER, FIVE AND A HALF HOURS AFTER THE PROCEDURE THE PATIENT FELT SICK. FIVE HOURS LATER THE PATIENT LOST STRENGTH IN HER ARM AND LEFT LEG. A CT SCAN WAS PERFORMED BUT THERE WAS NOTHING FOUND. THE TRIAL LEADS WERE REMOVED IN ORDER TO PERFORM AND MRI. THE MRI FOUND A HEMATOMA AT C5 AND T1. THE HEMATOMA WAS REMOVED SURGICALLY AND HAS RESOLVED. THE PATIENT WAS PRESCRIBED CORTICOSTEROIDS. THE PHYSICIAN BELIEVES THE SURGERY WAS SUCCESSFUL AND THAT THE DEVICE NOT CAUSE THE HEMATOMA BUT IS UNSURE. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR PARAPLEGIC REHABILITATION AND IS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358694 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |