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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-2218-70E
Medical Device Problem Code Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes Undesired Nerve Stimulation (1980); Anxiety (2328); Discomfort (2330)
Date of Event 07/26/2018
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient was experiencing stomach issues and it was discovered that the patient was having anxiety issues that could be affecting the stomach.It was also reported that the patient had soreness in an unknown area and had lost coverage in the left arm and wrist.The patient was prescribed anxiety medication and underwent a lead pull procedure.
 
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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 Key7824720
Report Number3006630150-2018-60725
Device Sequence Number19118380
Product Code LGW
UDI-Device Identifier08714729820741
UDI-Public08714729820741
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/28/2018
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 Date01/04/2020
Device Model NumberSC-2218-70E
Device Catalogue NumberSC-2218-70E
Device Lot Number5018657
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/01/2018
Initial Report FDA Received Date08/28/2018
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 Age51 YR
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