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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1132
Device Problem Defective Device (2588)
Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Sn: (b)(4). The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics. The reported event was not confirmed. Therefore no problem was detected. Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: (b)(4), model: sc-8336-70, serial: (b)(4), batch: 18712842.
 
Event Description
It was reported that the patient had a brain bleed or possible stroke. It was also reported that the patients ipg was non functional. It was unknown if the possible stroke was device related. The patient underwent an explant procedure wherein the ipg and lead were removed. The explanted ipg was returned.
 
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Brand NamePRECISION SPECTRA
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11327902
MDR Text Key231978946
Report Number3006630150-2021-00472
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
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 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/05/2018
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number18765242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2016
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: 02/15/2021 Patient Sequence Number: 1
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