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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 Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Discomfort (2330); Inadequate Pain Relief (2388); No Code Available (3191)
Event Date 09/24/2018
Event Type  Injury  
Manufacturer Narrative
Model number/catalog number: sc-8216-50: serial number: (b)(4), batch/lot number: 19929004, model/catalog description: artisan lead 50 cm. The explanted devices were not returned to bsn as they were discarded by the medical facility.
 
Event Description
A report was received that the patient was experiencing inadequate stimulation. Patient stated that the ipg felt uncomfortable and the lead was impinging and possibly damaging the other nerves. Physician did not suspect device malfunction. The patient underwent an explant procedure and was doing well postoperatively.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key7976231
MDR Text Key124060685
Report Number3006630150-2018-61413
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 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/15/2019
Device Model NumberSC-1132
Device Catalogue NumberSC-1132
Device Lot Number20289024
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 Received03/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2017
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: 10/17/2018 Patient Sequence Number: 1
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