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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2352-50E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Stroke/CVA (1770); No Code Available (3191)
Date of Event 06/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model: sc-2352-50e; serial/lot: (b)(4); description: linear 3-4 trial lead 50 cm.
 
Event or Problem Description
It was reported that the patient experienced a stroke during his implant trial and was hospitalized.No further information could be obtained.
 
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Brand Name
LINEAR 3-4
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 Key10193027
Report Number3006630150-2020-02612
Device Sequence Number2329517
Product Code LGW
UDI-Device Identifier08714729789703
UDI-Public08714729789703
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/24/2020
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 Date02/05/2022
Device Model NumberSC-2352-50E
Device Catalogue NumberSC-2352-50E
Device Lot Number7070767
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/01/2020
Initial Report FDA Received Date06/24/2020
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 Age79 YR
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