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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CLIK X MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION CLIK X MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-4319
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Discomfort (2330); No Code Available (3191)
Date of Event 10/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-2408-56, serial number: (b)(4), batch/lot number: 5033777/5034797, model/catalog description: avista mri perc lead kit 56 cm.
 
Event or Problem Description
A report was received that the patient was experiencing tenderness over the midline incision.The patient underwent an anchor revision procedure wherein the physician buried it deeper.The patient was doing well postoperatively.
 
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Brand Name
CLIK X MRI
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key8428656
Report Number3006630150-2019-01111
Device Sequence Number13775143
Product Code LGW
UDI-Device Identifier08714729905325
UDI-Public08714729905325
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/18/2019
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 Date02/22/2020
Device Model NumberSC-4319
Device Catalogue NumberSC-4319
Device Lot Number21755195
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/21/2019
Initial Report FDA Received Date03/18/2019
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 Age51 YR
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