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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-4254
Device Problems Use of Device Problem (1670); Structural Problem (2506)
Patient Problem Injury (2348)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-surg acc, upn: (b)(4), model : sc-4254, serial : n/a, lot: 24397747.

 
Event Description

It was reported that during a deep brain stimulator implant procedure, the physician experienced difficulty using the tunneling tools when trying to implant the lead extension. The physician used two different tunneling tools which both bent and damaged the silicone on the tools. The physician then had to make an additional incision in the middle of the patients neck to pass the tunneling tool to the chest in which the lead extension was successfully implanted. The patient is doing well post-operatively. The devices will not be returned as they were disposed of by the medical facility.

 
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Brand NameNA
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
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11038606
MDR Text Key222370069
Report Number3006630150-2020-06272
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeCO
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
Report Date 12/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/13/2021
Device MODEL NumberSC-4254
Device Catalogue NumberSC-4254
Device LOT Number24397806
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 Received12/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2019
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: 12/18/2020 Patient Sequence Number: 1
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