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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erosion (1750); Unspecified Infection (1930); Inflammation (1932)
Event Date 06/02/2021
Event Type  Injury  
Event Description

It was reported that the patient was experiencing inflammation and infection at the implantable pulse generator (ipg) site. The patient underwent an explant procedure.

 
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Brand NamePRECISION SPECTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasia
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12052332
MDR Text Key258502960
Report Number3006630150-2021-03161
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/16/2019
Device MODEL NumberSC-1132
Device Catalogue NumberSC-1132
Device LOT Number20651282
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/16/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/23/2021 Patient Sequence Number: 1
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