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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Undesired Nerve Stimulation (1980); Patient Problem/Medical Problem (2688)
Event Date 01/02/2018
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the patient underwent an explant procedure wherein everything was explanted. The physician believed that the symptoms were not device related. No complications noted. No device malfunction was suspected.
 
Event Description
A report was received that the scs (spinal cord stimulator) was causing patient to experience stomach upset and even when the device was turned off. The patient will undergo an explant procedure.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-8216-70, serial #: (b)(4). Description: artisan surgical lead, 70cm.
 
Event Description
A report was received that the scs (spinal cord stimulator) was causing patient to experience stomach upset and even when the device was turned off. The patient will undergo an explant procedure.
 
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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 Key7195378
MDR Text Key109810006
Report Number3006630150-2018-00044
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729821526
UDI-Public08714729821526
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 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/16/2016
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 Received02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2014
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: 01/16/2018 Patient Sequence Number: 1
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