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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 Patient Problem/Medical Problem (2688); No Information (3190)
Event Date 05/04/2018
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2316-50, serial#: (b)(4) ,description: infinion 1x16 perc lead kit-50 cm model#: sc-3400-30, serial#: (b)(4), description: infinion splitter 2x8 kit (30 cm) model#: sc-4318, lot#: 18892121, description: clik x anchor the explanted devices were not returned to bsn.

 
Event Description

A report was received that the patient underwent an explant procedure for an unknown reason.

 
Manufacturer Narrative

Additional information was received that the patient had lost weight and did not need the scs (spinal cord stimulator) any longer.

 
Event Description

A report was received that the patient underwent an explant procedure for an unknown reason.

 
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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 Key7749122
MDR Text Key116035226
Report Number3006630150-2018-02290
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN Number030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/04/2018
Device MODEL NumberSC-1132
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/11/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/03/2018 Patient Sequence Number: 1
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