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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hematoma (1884); Paralysis (1997)
Event Date 04/25/2017
Event Type  Injury  
Event Description
A report was received that the patient started to developed symptoms of paralysis shortly after the implant procedure. The patient could not feel anything, no motor or sensory function, it was a complete loss or paralysis. A day after the implant procedure, the patient regained eighty percent (80%) of paralysis and could now stand. The physician was not sure whether the event was related to the device or procedure. Ten (10) days after, the patient reported that she has fully recovered but was a little weak. The physician believed that it was probably be a post-surgical hematoma that got evacuated and may have aggravated a spinal cord compression from edema due to a recent surgery.
 
Manufacturer Narrative
Additional information was received that the patient has been hospitalized and was prescribed with antibiotics for postoperative prophylaxis. It was also noted that the patient was provided steroids and have received therapy for the patient to walk again.
 
Event Description
A report was received that the patient started to developed symptoms of paralysis shortly after the implant procedure. The patient could not feel anything, no motor or sensory function, it was a complete loss or paralysis. A day after the implant procedure, the patient regained eighty percent (80%) of paralysis and could now stand. The physician was not sure whether the event was related to the device or procedure. Ten (10) days after, the patient reported that she has fully recovered but was a little weak. The physician believed that it was probably be a post-surgical hematoma that got evacuated and may have aggravated a spinal cord compression from edema due to a recent surgery.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key6588236
MDR Text Key75867258
Report Number3006630150-2017-01787
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Model NumberSC-1132
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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