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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-8336-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994)
Event Date 02/25/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator model #: sc-4318 lot #: 19882846 description: clik x anchor the explanted devices were not returned to bsn as they were kept by medical facility.
 
Event Description
A report was received that the patient was experiencing pain from the posterior to the anterior ribs. Computed tomography (ct) myelogram was taken and it was determined that the paddle was touching a nerve. The patient underwent a revision procedure wherein the ipg and lead were replaced. No device malfunction was suspected. The patient was doing well postoperatively.
 
Manufacturer Narrative
Additional information was received that the reason for the ipg and lead replacement was due to physicians preference.
 
Event Description
A report was received that the patient was experiencing pain from the posterior to the anterior ribs. Computed tomography (ct) myelogram was taken and it was determined that the paddle was touching a nerve. The patient underwent a revision procedure wherein the ipg and lead were replaced. 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 Key7346257
MDR Text Key102705948
Report Number3006630150-2018-01059
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 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/04/2019
Device Model NumberSC-8336-50
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 Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2017
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: 03/16/2018 Patient Sequence Number: 1
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