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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-8336-50
Device Problems Circuit Failure (1089); Material Separation (1562); Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/24/2018
Event Type  Malfunction  
Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1132 serial #: (b)(4), description: precision spectra implantable pulse generator.

 
Event Description

A report was received that the patient was experiencing lack of stimulation due to the paddle lead no longer functioning and was not fully intact. The physician believed that the ipg might have shorted out with the lead. The patient underwent an ipg and lead replacement procedure. Device malfunction was suspected. The patient was doing well postoperatively.

 
Manufacturer Narrative

Sc-8336-50 (sn (b)(4)) device evaluation indicated that the complaint could not be investigated due to incomplete device return. The lead bodies were cleanly cut and the paddle was not returned. The clean cut damage is a result of a typical explant procedure and it is not considered a failure. Sc-1132 (sn (b)(4)) device evaluation indicated that the complaint could not be investigated due to complete device damage after the explant procedure. The device would not be charged nor linked due to damaged u2_asic. The device sleep current was extremely excessive (22. 2 ma). Vh to ground was short (244 ohm). The patient data was captured using an external power source. The device had been normal prior to the explant procedure, suggesting the device damage was damaged during the procedure.

 
Event Description

A report was received that the patient was experiencing lack of stimulation due to the paddle lead no longer functioning and was not fully intact. The physician believed that the ipg might have shorted out with the lead. The patient underwent an ipg and lead replacement procedure. Device malfunction was suspected. The patient was doing well postoperatively.

 
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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 Key7598302
MDR Text Key111012541
Report Number3006630150-2018-02123
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 07/26/2018
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 Date08/11/2018
Device MODEL NumberSC-8336-50
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/17/2016
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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