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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8352-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Staphylococcus Aureus (2058); No Code Available (3191)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative

Exact date unknown, event occurred in early august.

 
Event Description

It was reported that the patient had a methicillin-resistant staphylococcus aureus (mrsa) infection. It was also noted that the patient was experiencing increased pain and had to go to the emergency room (er) three times before the patient was diagnosed with infection. The physician believed that the infection was not device related. The patient was prescribed with antibiotics and underwent an explant procedure. The explanted device was not returned.

 
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Brand NameCOVEREDGE X 32
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
road 698, lot no. 12
dorado PR 00646 -260
00646-2602
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10760369
MDR Text Key213844696
Report Number3006630150-2020-05258
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,Followup
Report Date 11/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-8352-50
Device Catalogue NumberSC-8352-50
Device LOT Number7070028
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 Received11/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2020
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: 10/30/2020 Patient Sequence Number: 1
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