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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8352-70
Medical Device Problem Codes Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/25/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
 
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation due to the lead that had migrated two levels down from original placement.The patient underwent a revision procedure wherein the lead was repositioned and remains implanted in the patients body.
 
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Brand Name
COVEREDGE X 32
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 Key10200643
Report Number3006630150-2020-02645
Device Sequence Number11321462
Product Code LGW
UDI-Device Identifier08714729832690
UDI-Public08714729832690
Combination Product (Y/N)N
Initial Reporter StateLA
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) 06/26/2020
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 Date11/14/2021
Device Model NumberSC-8352-70
Device Catalogue NumberSC-8352-70
Device Lot Number1107903
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/07/2020
Initial Report FDA Received Date06/26/2020
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 Age57 YR
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