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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC

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MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number NMRM6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: 8785 neuro accessory, implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient had revision of their pain pump and a antibacterial absorbable envelope was implanted during the revision. Approximately twenty days post the revision the patient had developed an infection and the system was extracted. It was noted that at the time of the extraction procedure the antibacterial absorbable envelope was completely dissolved / absorbed. No further patient complications have been reported as a result of this event.

 
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Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
suites g, e
mounds view,mn NJ 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
suites g, e
mounds view,mn NJ 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11685443
MDR Text Key246031937
Report Number3005619263-2021-00018
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150291
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 04/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberNMRM6133
Device Catalogue NumberNMRM6133
Device LOT NumberR138553
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 Received04/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/23/2020
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: 04/19/2021 Patient Sequence Number: 1
Treatment
8637-20, NEURO PUMP, 8780, CATHETER
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