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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 Migration or Expulsion of Device (1395); Charging Problem (2892); Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Date 08/29/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure due to not holding a charge. The physician was unsure if device malfunction was suspected. 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 was experiencing pain at the ipg site and was having difficulty to charge due to the battery was visibly protruding and tilted. Database analysis showed charge signs of poor charger to ipg coupling and the charger thermistor triggering often which can delay charging times. The patient will undergo an ipg revision procedure. No immediate course of action needed at this time.
 
Event Description
A report was received that the patient was experiencing pain at the ipg site and was having difficulty to charge due to the battery was visibly protruding and tilted. Database analysis showed charge signs of poor charger to ipg coupling and the charger thermistor triggering often which can delay charging times. The patient will undergo an ipg revision procedure. No immediate course of action needed at this time.
 
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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 Key6976277
MDR Text Key114850407
Report Number3006630150-2017-04165
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 11/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/17/2018
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 Received11/09/2017
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

Patient Treatment Data
Date Received: 10/25/2017 Patient Sequence Number: 1
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