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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 06/27/2019
Event Type  Injury  
Event Description

A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation. The patient underwent an ipg explant procedure.

 
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Brand NamePRECISION SPECTRA
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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8809347
MDR Text Key151654873
Report Number3006630150-2019-03711
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/15/2018
Device MODEL NumberSC-1132
Device Catalogue NumberSC-1132
Device LOT Number19584525
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2016
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: 07/19/2019 Patient Sequence Number: 1
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