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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 Positioning Problem (3009)
Patient Problems Edema (1820); No Code Available (3191)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

 
Event Description

It was reported that the patient was unable to connect the charger to the ipg due to increased amount of edema in the pocket site. The physician aspirated more than fifteen milliliter of blood from the pocket twice. The physician believed that the edema was the patients physical reaction in creating the pocket and the surgical procedure itself. This was not device or procedure related. The patient underwent a revision procedure wherein the ipg pocket site was relocated. The patient was doing well postoperatively.

 
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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 Key10986869
MDR Text Key220881036
Report Number3006630150-2020-06137
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 12/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1160
Device Catalogue NumberSC-1160
Device LOT Number363481
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 Received11/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/27/2019
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: 12/10/2020 Patient Sequence Number: 1
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