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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problems Device Inoperable (1663); Charging Problem (2892)
Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2018
Event Type  Malfunction  
Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2317-50 serial #: (b)(4) description: infiniontm cx 50 cm lead model #: sc-3138-25 serial #: (b)(4) description: scs phiii ext 25cm.

 
Event Description

A report was received that the patients ipg was non-functional. The patient will undergo an explant procedure.

 
Manufacturer Narrative

Additional information was received that there will be no further course of action at this time.

 
Event Description

A report was received that the patients ipg was non-functional. The patient will undergo an explant procedure.

 
Search Alerts/Recalls

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Brand NamePRECISION SPECTRA
Type of DeviceSPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7596406
MDR Text Key110901458
Report Number3006630150-2018-01824
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN Number030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/18/2018
Device MODEL NumberSC-1132
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/23/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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