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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-4319
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/24/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-2408-56, serial #: (b)(4), description: avista mri perc lead kit, 56 cm.
 
Event or Problem Description
A report was received that the patient was experiencing midline pain.It was also reported that the main reason for anchor revision was discomfort.The patient underwent a revision procedure wherein the clik anchor was relocated by cutting the suture and re-sutured with a new fixate.The patient was doing 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 Key6857833
Report Number3006630150-2017-03447
Device Sequence Number10921864
Product Code LGW
UDI-Device Identifier08714729905325
UDI-Public08714729905325
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/24/2017
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 Date03/20/2019
Device Model NumberSC-4319
Device Lot Number200001924
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/24/2017
Initial Report FDA Received Date09/12/2017
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 Age63 YR
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