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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION® SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1110
Device Problems Device Stops Intermittently (1599); Reset Problem (3019)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/02/2014
Event Type  malfunction  
Event Description
A report was received that the patient's ipg was turning off by itself numerous times. It was noted that the patient had a non-device related surgery. Ipg database analysis revealed no anomalies. The history counter showed multiple resets have occurred. The ipg appeared to be working as expected. The patient will undergo an ipg replacement procedure. The physician suspected device malfunction.
 
Manufacturer Narrative
Sc-1110 (sn (b)(4)) device evaluation indicated that the complaint was not verified. The reported stimulation anomaly was not observed as the ipg was investigated with known good test leads. The monitored stimulation on an oscilloscope found that the outputs were consistent and amplitude/pulse widths were verified to be correct on all the electrodes. Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue as a result of faulty insulation. The ipg passed all the required tests and revealed no anomalies. The complaint of the device turning off by it couldn't be duplicated.
 
Event Description
A report was received that the patient's ipg was turning off by itself numerous times. It was noted that the patient had a non-device related surgery. Ipg database analysis revealed no anomalies. The history counter showed multiple resets have occurred. The ipg appeared to be working as expected. The patient will undergo an ipg replacement procedure. The physician suspected device malfunction.
 
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Brand NamePRECISION®
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 Key5639275
MDR Text Key44667726
Report Number3006630150-2016-01169
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
030017
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 09/02/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2007
Device Model NumberSC-1110
Other Device ID NumberM365SC11100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2007
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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