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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8336-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Paralysis (1997)
Event Date 09/28/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(4), batch: 515901. The explanted devices will not be returned to bsc for analysis.
 
Event Description
It was reported that 6 hours following the initial scs implant procedure, the patient could not move his legs. The patient was taken back to the or where the paddle lead was removed to relieve pressure on the spinal cord. The following day, the patient had a ct scan which found an epidural hematoma at the t8 and t9 vertebrae. The hematoma was evacuated and the ipg was explanted. According to the physician, the patient has regained full use of his legs.
 
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Brand NameCOVEREDGE 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 Key12583057
MDR Text Key274934831
Report Number3006630150-2021-05592
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729832669
UDI-Public08714729832669
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
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 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-8336-50
Device Catalogue NumberSC-8336-50
Device Lot Number7075606
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 Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2021
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: 10/06/2021 Patient Sequence Number: 1
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