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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION LINEAR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-2158-50
Medical Device Problem Code Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Age at time of event: (b)(6) years old.Model number/catalog number: sc-2218-50.Serial number: (b)(4).Batch/lot number: 5083175.Model/catalog description: linear st lead kit 50 cm.The explanted devices were not returned to bsn.
 
Event or Problem Description
A report was received that the patient was experiencing inadequate pain relief.The patient underwent a lead replacement procedure and was doing well postoperatively.
 
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Brand Name
LINEAR
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 Key8855443
Report Number3006630150-2019-03985
Device Sequence Number11380229
Product Code LGW
UDI-Device Identifier08714729767695
UDI-Public08714729767695
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/02/2019
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 Date10/16/2016
Device Model NumberSC-2158-50
Device Catalogue NumberSC-2158-50
Device Lot Number17354425
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2019
Initial Report FDA Received Date08/02/2019
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 Age71 YR
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