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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 Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/14/2018
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patients anchor was somewhat protruding but no skin breakage was noted.The patient underwent surgery to suture the anchor down.
 
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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 Key7684404
Report Number3006630150-2018-60136
Device Sequence Number13795555
Product Code LGW
UDI-Device Identifier08714729905325
UDI-Public08714729905325
Combination Product (Y/N)N
Initial Reporter StateTX
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) 07/12/2018
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 Date07/27/2019
Device Model NumberSC-4319
Device Catalogue NumberSC-4319
Device Lot Number20928941
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2018
Initial Report FDA Received Date07/12/2018
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 Age82 YR
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