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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-2218-70
Device Problems Unexpected Therapeutic Results (1631); Migration (4003)
Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: 19591001.
 
Event Description
It was reported that the patients spinal cord stimulator (scs) device was causing pressure around the mid back and was not providing an adequate pain relief. The patients leads were evaluated under fluoroscopy and it was found that both of the leads had migrated. The patent underwent a revision procedure wherein both of the leads were replaced. The patient was doing well post-operatively and the explanted leads were discarded by the medical facility.
 
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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
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12427691
MDR Text Key270290598
Report Number3006630150-2021-04980
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 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2019
Device Model NumberSC-2218-70
Device Catalogue NumberSC-2218-70
Device Lot Number2000018683
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 Received08/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
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: 09/06/2021 Patient Sequence Number: 1
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