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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 CMRM6122
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Event Date 07/19/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that two days post implant of an implantable pulse generator (ipg) with an antibacterial absorbable envelope the patient presented to the emergency department for suspected cellulitis that was adjacent to the device pocket. The physician suspected the response was due to a possible allergic reaction. The patient was given antibiotics and the ipg and antibacterial absorbable envelope remain in use. 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
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11619044
MDR Text Key243927849
Report Number2182208-2021-01339
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130943
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 04/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/08/2021
Device MODEL NumberCMRM6122
Device Catalogue NumberCMRM6122
Device LOT NumberR131240
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 Received03/08/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/13/2020
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: 04/06/2021 Patient Sequence Number: 1
Treatment
W1DR01 IPG, 5076-52 LEAD, 5076-45 LEAD
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