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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2366-30
Medical Device Problem Codes High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the patient underwent a revision procedure to replace a lead with high impedances wherein causing the patient to experience inadequate stimulation.Following the procedure the patient was noted to be doing well and fully recovered.
 
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Brand Name
LINEAR 3-6
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11240246
Report Number3006630150-2021-00176
Device Sequence Number3718564
Product Code LGW
UDI-Device Identifier08714729789659
UDI-Public08714729789659
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/27/2021
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date05/24/2020
Device Model NumberSC-2366-30
Device Catalogue NumberSC-2366-30
Device Lot Number5004673
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/12/2021
Initial Report FDA Received Date01/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
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