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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-4316
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Discomfort (2330)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
Device manufacture date: march 2011.
 
Event Description
A report was received that the patient was experiencing discomfort due to the anchor protruding in the back. No actual skin breakage was noted. The patient underwent a revision procedure wherein the physician opened the midline incision and dissected and tucked the anchor deeper. No 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 Key6965393
MDR Text Key89842131
Report Number3006630150-2017-04155
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
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2013
Device Model NumberSC-4316
Device Lot Number14228624
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 Received10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/20/2017 Patient Sequence Number: 1
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