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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1160
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/18/2021
Event Type  Injury  
Event Description
It was reported that the patient had not received adequate pain relief since the patient was implanted and wanted to get the scs spinal cord stimulator system removed. The patient underwent an explant procedure of the scs system. The patient has fully recovered.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7072670. Product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7072693.
 
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Brand NameSPECTRA WAVEWRITER
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 Key12929752
MDR Text Key282040561
Report Number3006630150-2021-06925
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/03/2021
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? No
Device Operator
Device Model NumberSC-1160
Device Catalogue NumberSC-1160
Device Lot Number375199
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2020
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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