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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Irritation (1941); No Code Available (3191)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-70, serial: (b)(4), batch: 20729754/21437310.

 
Event Description

It was reported that the patient's ipg was placed low in the flank and was irritating patient as she sat on it. The patient was not getting any pain relief as well despite several reprogramming. The patient underwent a full system explant procedure. The explanted ipg and leads will not be returned.

 
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Brand NamePRECISION MONTAGE MRI
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 Key10984842
MDR Text Key220708911
Report Number3006630150-2020-06125
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 EXPIRATION Date11/06/2019
Device MODEL NumberSC-1200
Device Catalogue NumberSC-1200
Device LOT Number351061
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 Received11/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2017
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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