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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-5160
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Fluid Discharge (2686); No Code Available (3191)
Date of Event 10/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient was experiencing itchiness on the upper right leg and back due to a tape reaction.A clear fluid was noted around the patients underpants.The patient was prescribed with a medication.
 
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Brand Name
SPECTRA WAVEWRITER
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 Key9279991
Report Number3006630150-2019-06234
Device Sequence Number398458
Product Code LGW
UDI-Device Identifier08714729952046
UDI-Public08714729952046
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/05/2019
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 Model NumberSC-5160
Device Catalogue NumberSC-5160
Device Lot Number735292
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/17/2019
Initial Report FDA Received Date11/05/2019
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 Age57 YR
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