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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 Pain (1994); Paralysis (1997)
Event Date 05/16/2022
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: 7102046.
 
Event Description
It was reported that following a lead revision procedure, mfg.Report 3006630150-2022-02696, the patient was experiencing pain and could not move her legs.It was noted that during the mentioned lead revision that the physician had a difficult time getting the leads into the correct spot.The physician noted that something was impeding them from progressing upwards, however after multiple attempts he was able to implant the leads in the correct position.The physician believes that the leads were placed intrathecally.It is unknown what caused the pain.A computed tomography scan was performed, however the results are not known.The patient underwent a lead explant procedure and post-operatively the patient was able to move her legs, and was no longer experiencing pain.The explanted leads will not be returned as they were kept by the facility.
 
Event Description
It was reported that following a lead revision procedure, mfg.Report 3006630150-2022-02696, the patient was experiencing pain and could not move her legs.It was noted that during the mentioned lead revision that the physician had a difficult time getting the leads into the correct spot.The physician noted that something was impeding them from progressing upwards, however after multiple attempts he was able to implant the leads in the correct position.The physician believes that the leads were placed intrathecally.It is unknown what caused the pain.A computed tomography scan was performed, however the results are not known.The patient underwent a lead explant procedure and post-operatively the patient was able to move her legs, and was no longer experiencing pain.The explanted leads will not be returned as they were kept by the facility.Additional information was received that the physician and neurosurgeon are unsure why this event occurred.The computed tomography scan will not be made available and therefore will not be provided.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: (b)(6).
 
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Brand Name
LINEAR ST
Type of Device
STIMULATOR, 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 Key14631242
MDR Text Key293529037
Report Number3006630150-2022-02748
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729767725
UDI-Public08714729767725
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 Physician
Type of Report Initial,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/21/2024
Device Model NumberSC-2218-50
Device Catalogue NumberSC-2218-50
Device Lot Number7106803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/08/2022
Supplement Dates Manufacturer Received06/10/2022
Supplement Dates FDA Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age74 YR
Patient SexFemale
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