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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative

Additional suspect medical device components involved in the event. Product family scs-ipg-pc. Upn m365sc14320, model sc-1432, serial (b)(4), batch 202455.

 
Event Description

It was reported that approximately 45 minutes to 1 hour post implant procedure the patient had limited movement on the leg. Nothing happened during the implant procedure that may have caused or contributed to the issue. It was determined through a magnetic resonance imaging that the lead was pushing the spinal cord. All device components were explanted. The patient was doing well postoperatively. The patient is now doing considerably better, and has regained most of her function back. The patient is going to physical therapy every day, and is expected to have full recovery within six months. The explanted devices were kept by the facility and will not be returned.

 
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Brand NameCOVEREDGE X 32
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12350748
MDR Text Key267563046
Report Number3006630150-2021-04645
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-8352-50
Device Catalogue NumberSC-8352-50
Device LOT Number1113734
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/20/2021 Patient Sequence Number: 1
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