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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-8216-50
Device Problem No Apparent Adverse Event (3189)
Patient Problems Cerebrospinal Fluid Leakage (1772); Edema (1820)
Event Date 03/14/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received that the patient underwent an explant procedure wherein the ipg and leads were removed. No device malfunction was suspected. Additional suspect medical device component involved in the event: model#: sc-1132 serial #: (b)(4), description: precision spectra implantable pulse generator. The explanted devices were not returned to bsn as they were kept by the medical facility.
 
Event Description
A report was received that the patient had a fluid build-up at the implant site that was determined to be a cerebrospinal fluid leak. The physician believed that the cause was from a durotomy that occurred in the cervical spine during the scs implant. Patient underwent dural repair and fluid aspiration. The physician confirmed that the complication was not device related. The patient was doing well post-operatively.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-8216-70 serial#: (b)(4) description: artisan surgical lead, 70cm 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 had a fluid build-up at the implant site that was determined to be a cerebrospinal fluid leak. The physician believed that the cause was from a durotomy that occurred in the cervical spine during the scs implant. Patient underwent dural repair and fluid aspiration. The physician confirmed that the complication was not device related. The patient was doing well post-operatively.
 
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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 Key6455343
MDR Text Key106455192
Report Number3006630150-2017-01119
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 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/16/2017
Device Model NumberSC-8216-50
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 Received08/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2015
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: 04/03/2017 Patient Sequence Number: 1
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