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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Neck Pain (2433); No Code Available (3191)
Event Date 02/04/2019
Event Type  Injury  
Event Description
A report was received that the patient was experiencing neck pain, headache, nausea and vomiting and dizziness following an implant procedure. The physician believed that the symptoms were not device related however it was aggravated due to an uncomfortable positioning during implant. The patient was given anti-nausea medication, muscle relaxers, and trigger point injections in the neck.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8355771
MDR Text Key136715390
Report Number3006630150-2019-00693
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/16/2020
Device Model NumberSC-1200
Device Catalogue NumberSC-1200
Device Lot Number352816
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 Received02/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2018
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: 02/20/2019 Patient Sequence Number: 1
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