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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1232
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Muscle Weakness (1967); Paralysis (1997); Insufficient Information (4580)
Event Date 06/12/2021
Event Type  Death  
Manufacturer Narrative
Report source (other): patient advocate. Additional suspect medical device components involved in the event: product family: scs-paddle leads-mri. Upn: (b)(4). Model: sc-8436-50. Serial: (b)(4). Batch: 7074091.
 
Event Description
It was reported the patient experienced weakness in his legs the evening after being implanted with the spinal cord stimulation (scs) system. He was then diagnosed with an epidural hematoma and underwent an explant procedure where the entire scs system was removed. Post-explant procedure the patient was not able to move his legs, and approximately two months later the patient passed away. The physician assessed that the reported events were not device related, but was due to a blood disorder that resulted in chronic low platelet counts that prevented clotting. No further information has been obtained despite good faith efforts.
 
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Brand NameWAVEWRITER ALPHA
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
cashel road
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12529242
MDR Text Key273286664
Report Number3006630150-2021-05359
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729985099
UDI-Public08714729985099
Combination Product (y/n)N
Reporter Country CodeUS
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSC-1232
Device Catalogue NumberSC-1232
Device Lot Number512962
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 Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2021
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: 09/24/2021 Patient Sequence Number: 1
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