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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2218-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Weakness (2145)
Event Date 12/16/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional suspect medical device components involved in the event: model #: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm; model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.
 
Event Description
A report was received that after a revision, the patient had trouble walking.The patient had normal neurological check however, bilateral leg weakness noted upon standing while still in postoperative care before discharge from a same- day- surgery.An emergency computerized tomography (ct) scan was taken and revealed a negative result.The patient was discharged after a negative finding but the symptom was not resolved as expected by the physician.The physician believed that the patient might have injured a nerve due to the position on the operating room table and did not believe that it was caused by the device.The patient underwent an explant procedure so that an mri of the spine could be obtained.
 
Manufacturer Narrative
Additional information was received that the result of the magnetic resonance imaging (mri) of the spine was negative.The patient was referred to a neurologist.Device evaluation indicated that the devices passed all tests performed.The ipg exhibited normal characteristics.The ipg profiles revealed no anomalies.Leads visual/x-ray inspections and impedance test were performed to ensure the device integrity and no anomalies were found.
 
Event Description
A report was received that after a revision, the patient had trouble walking.The patient had normal neurological check however, bilateral leg weakness noted upon standing while still in postoperative care before discharge from a same- day- surgery.An emergency computerized tomography (ct) scan was taken and revealed a negative result.The patient was discharged after a negative finding but the symptom was not resolved as expected by the physician.The physician believed that the patient might have injured a nerve due to the position on the operating room table and did not believe that it was caused by the device.The patient underwent an explant procedure, so that an mri of the spine could be obtained.
 
Manufacturer Narrative
Additional information was received that there is no further course of action taken regarding the patient's symptoms.
 
Event Description
A report was received that after a revision, the patient had trouble walking.The patient had normal neurological check however, bilateral leg weakness noted upon standing while still in postoperative care before discharge from a same- day- surgery.An emergency computerized tomography (ct) scan was taken and revealed a negative result.The patient was discharged after a negative finding but the symptom was not resolved as expected by the physician.The physician believed that the patient might have injured a nerve due to the position on the operating room table and did not believe that it was caused by the device.The patient underwent an explant procedure so that an mri of the spine could be obtained.
 
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Brand Name
PRECISION®
Type of Device
SPINAL 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 Key5359381
MDR Text Key35606049
Report Number3006630150-2015-03478
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/30/2017
Device Model NumberSC-2218-50
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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