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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2352-50
Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/04/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads: upn: m365sc2352500, model: sc-2352-50, serial: (b)(4), batch: 7072748.

 
Event Description

It was reported that the patient was experiencing loss of therapy. High impedances were noted on one of the two leads. An x-ray revealed that one of the leads was fractured. The patient had a particularly violent sneeze that may have caused it. It is not known which of the two leads had the high impedances and fracture. It was noted that during the permanent implant procedure, the leads were sutured, not anchored. Reprogramming will be performed to avoid the damaged lead. The leads remain implanted and there is no intention to surgically revise.

 
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Brand NameLINEAR 3-4
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
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12373609
MDR Text Key268340311
Report Number3006630150-2021-04776
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUK
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 08/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-2352-50
Device Catalogue NumberSC-2352-50
Device LOT Number7072796
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 Received08/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/16/2021
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: 08/26/2021 Patient Sequence Number: 1
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