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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-2218-70E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fever (1858); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event 09/14/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-2218-70e serial #: (b)(4) description: trial linear st lead, 70cm.
 
Event or Problem Description
A report was received that while on trial the patient experienced allergic reactions.Symptoms were itching and fever.The patient underwent a lead pull and was doing well postoperatively.
 
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Brand Name
PRECISION MONTAGE MRI
Common Device Name
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key6948019
Report Number3006630150-2017-03882
Device Sequence Number682913
Product Code LGW
UDI-Device Identifier08714729820741
UDI-Public08714729820741
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date10/06/2017
Device Model NumberSC-2218-70E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/19/2017
Initial Report FDA Received Date10/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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