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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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BOSTON SCIENTIFIC NEUROMODULATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 03/08/2019
Event Type  Injury  
Event Description

A report was received per social media that the patients body rejected the implant. The patient underwent an explant procedure. No further information could be obtained.

 
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Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8456956
MDR Text Key140026266
Report Number3006630150-2019-01364
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial
Report Date 03/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/27/2019 Patient Sequence Number: 1
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