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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 Failure to Charge (1085); Migration or Expulsion of Device (1395); Device Inoperable (1663)
Patient Problem Pain (1994)
Event Date 05/10/2018
Event Type  Injury  
Event Description

A report was received that the patient's scs (spinal cord stimulator) was not working. It was also noted that the ipg was turning in the pocket which was causing pain when patient leans against it. The patient will undergo an explant procedure.

 
Manufacturer Narrative

Additional information was received that the patient underwent an ipg explant procedure. The explanted device was not returned to bsn as it was kept by the medical facility. It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.

 
Event Description

A report was received that the patient's scs (spinal cord stimulator) was not working. It was also noted that the ipg was turning in the pocket which was causing pain when patient leans against it. The patient will undergo an explant procedure.

 
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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 Key7606057
MDR Text Key111204891
Report Number3006630150-2018-02097
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
1 Patient Was Involved in the Event
Date FDA Received06/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/26/2016
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 Received07/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/02/2014
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: 06/15/2018 Patient Sequence Number: 1
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