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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 Unexpected Therapeutic Results (1631)
Patient Problems Stroke/CVA (1770); Inadequate Pain Relief (2388)
Event Date 11/12/2021
Event Type  Injury  
Event Description
It was reported that the patient was experiencing inadequate stimulation and underwent a reprogramming session. During follow up communication the patient disclosed that she had recently suffered a stroke. The cause of the stroke is unknown. The patient has reportedly recovered and obtained coverage.
 
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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 Key12929643
MDR Text Key282094057
Report Number3006630150-2021-06919
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC-1232
Device Catalogue NumberSC-1232
Device Lot Number515872
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2021
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: 12/03/2021 Patient Sequence Number: 1
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