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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2218-30
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/23/2018
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient had high impedances on all the contacts of lead one, and two contacts of lead two.The patient underwent a revision procedure wherein the two existing leads were repositioned.The patient regained good coverage.
 
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Brand Name
LINEAR ST
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 Key7795136
Report Number3006630150-2018-60632
Device Sequence Number1536814
Product Code LGW
UDI-Device Identifier08714729771180
UDI-Public08714729771180
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/17/2018
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 Date05/01/2012
Device Model NumberSC-2218-30
Device Catalogue NumberSC-2218-30
Device Lot Number13451433
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2018
Initial Report FDA Received Date08/17/2018
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 Age49 YR
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