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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-50
Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/05/2021
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event: upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 7071970.

 
Event Description

It was reported that the patient was experiencing loss of paresthesia of pain areas. High impedances were noted on both leads. The patient underwent a revision procedure in which the physician implanted one new lead, and upgraded the implantable pulse generator (ipg). The two leads that displayed high impedances remain implanted. The explanted ipg was discarded. No additional adverse patient effects were reported.

 
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Brand NameLINEAR ST
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12388759
MDR Text Key268878787
Report Number3006630150-2021-04863
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/27/2018
Device MODEL NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device LOT Number19518064
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 Received09/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2016
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: 08/30/2021 Patient Sequence Number: 1
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