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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC NEUROMODULATION PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1110
Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885)
Patient Problems Irritation (1941); Pain (1994); No Code Available (3191)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2019. Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2208-70, serial: (b)(4), batch: a32917/a37568.

 
Event Description

It was reported that the patient was having pain and ineffective therapy. It was also stated that touching his left arm worsens the pain. It was noted that the ipg was causing irritation at the site and has not worked for several years. All device components were explanted and will not be returned.

 
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Brand NamePRECISION
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 Key10676424
MDR Text Key211228764
Report Number3006630150-2020-04836
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2009
Device MODEL NumberSC-1110
Device Catalogue NumberSC-1110
Device LOT Number167600
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 Received09/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/22/2008
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: 10/14/2020 Patient Sequence Number: 1
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