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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISISON SPECTRA SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1132
Device Problems Device Inoperable (1663); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2018
Event Type  Malfunction  
Event Description

A report was received that the patients ipg was non-functional. The patient will undergo an ipg replacement procedure. Device malfunction was suspected.

 
Manufacturer Narrative

Additional information was received that that patients rc was not linking up to ipg. The patient underwent an ipg replacement procedure. The patient was doing well postoperatively. Sc-1132 sn (b)(4) device evaluation indicated that the ipg power was exhausting quickly due to excessive sleep current resulted from asic-u3 damage. In addition, electrode #25 was shorted to the vh node inside the asic. It was reported that the symptom appeared one day after the previous lead revision which is the source of the ipg damage.

 
Event Description

A report was received that the patients ipg was non-functional. The patient will undergo an ipg replacement procedure. Device malfunction was suspected.

 
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Brand NamePRECISISON 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 Key7659369
MDR Text Key113167984
Report Number3006630150-2018-02260
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 08/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/06/2018
Device MODEL NumberSC-1132
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/17/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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