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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Numbness (2415)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event product family: scs-linear leads upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: (b)(4); product family: scs-ipg-r-mri, upn: m365sc12000, model: sc-1200, serial: (b)(4), batch: (b)(4); product family: scs-lead fixation, upn: m365sc43180, model: sc-4318, lot 24900590, batch: 24900590.
 
Event Description
It was reported that the patient underwent an explant of a competitors paddle lead and implant of bsc system. Following the implant procedure, the patient woke up without feeling or movement from the solar plexus down. The patient was transferred to the hospital and underwent an explant procedure the same day. The patient is still suffering from paralysis. There is no further course of action. The physician does not believe the paralysis is related to the bsc system. The physician believes the removal of the competitors paddle lead to be the root of the issue.
 
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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
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 Key11586517
MDR Text Key242895224
Report Number3006630150-2021-01275
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number7081386
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 Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2020
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: 03/29/2021 Patient Sequence Number: 1
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