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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Burning Sensation (2146)
Event Date 11/18/2016
Event Type  Injury  
Event Description
A report was received that the patient suffered from nerve damage. It was noted that the patient¿s burning skin sensation was unbearable. Patient underwent an explant.
 
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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 Key6176687
MDR Text Key62439922
Report Number3006630150-2016-03730
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
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: 12/15/2016 Patient Sequence Number: 1
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