Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2366-70
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Erosion (1750)
Date of Event 11/22/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that this spinal cord stimulation (scs) system was explanted due to leads eroding through the skin.The location of the devices is unknown.No additional adverse patient effects were reported despite good faith efforts.
 
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 5003788.Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 5072721.Product family: scs-linear leads, upn: m365sc2366700, model: sc-2366-70, serial: (b)(6), batch: 7016412.Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7031633.Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7010536.Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7013151.Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7031701.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LINEAR 3-6
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key20805993
Report Number3006630150-2024-08235
Device Sequence Number9830823
Product Code LGW
UDI-Device Identifier08714729789567
UDI-Public08714729789567
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2024
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/28/2024
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
Operator of Device Lay User/Patient
Device Expiration Date11/01/2018
Device Model NumberSC-2366-70
Device Catalogue NumberSC-2366-70
Device Lot Number2000017016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2024
Initial Report FDA Received Date11/28/2024
Date Device Manufactured11/20/2013
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age77 YR
Patient SexMale
-
-