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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-8352-50
Medical Device Problem Codes Fracture (1260); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 09/24/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient was experiencing inadequate pain relief due to the lead falling out of the epidural space as confirmed through x-ray.The patient underwent a revision procedure wherein the lead was supposed to be moved back in its place however there were tears in the base of the paddle lead that the physician opted for a lead replacement instead.The explanted lead was not returned as it was kept by the medical facility.
 
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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 Key12680457
Report Number3006630150-2021-05925
Device Sequence Number4444355
Product Code LGW
UDI-Device Identifier08714729832683
UDI-Public08714729832683
Combination Product (Y/N)N
Initial Reporter StateWY
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/22/2021
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 Date06/24/2022
Device Model NumberSC-8352-50
Device Catalogue NumberSC-8352-50
Device Lot Number7070062
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/27/2021
Initial Report FDA Received Date10/22/2021
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 Age61 YR
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