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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 Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/03/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: exact date unknown, event occurred couple of months ago from the date the manufacturer was made aware.
 
Event or Problem Description
It was reported that the patient had a bottom row of contacts were detached which was confirmed via x-ray.The physician opted to replace the lead and patient was doing well postoperatively.The explanted lead will not be returned.
 
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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 Key12068458
Report Number3006630150-2021-03219
Device Sequence Number4899286
Product Code LGW
UDI-Device Identifier08714729832690
UDI-Public08714729832690
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 06/25/2021
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 Date02/23/2017
Device Model NumberSC-8352-70
Device Catalogue NumberSC-8352-70
Device Lot Number17717303
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date06/25/2021
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 Age68 YR
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