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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 Problem Unexpected Therapeutic Results (1631)
Patient Problems Cerebrospinal Fluid Leakage (1772); Inadequate Pain Relief (2388)
Event Date 11/18/2021
Event Type  Injury  
Event Description
It was reported that the patient had a cerebrospinal fluid leak due to a non device related laminectomy procedure. The patient underwent a lead revision procedure wherein the physician tried to fix the lead placements but did it wrong. The patient underwent another lead revision procedure wherein the linear leads were replaced with paddle leads. The patient was doing well post operatively. The explanted leads were not returned.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2352700, model: sc-2352-70, serial: (b)(4), batch: 7073088/7072836/7073087.
 
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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 Key13830916
MDR Text Key287528395
Report Number3006630150-2022-01127
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-2352-50
Device Catalogue NumberSC-2352-50
Device Lot Number7074439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2021
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: 03/20/2022 Patient Sequence Number: 1
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