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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 CMRM6133
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888); Discomfort (2330)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ddpc3d1: crt-d, 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 awoke and found a large amount of blood on the pillow and also had tenderness at the device implant site two days after the implant of a cardiac resynchronization therapy defibrillator (crt-d) with an absorbable envelope. Diagnostic testing revealed significant hematoma and wound dehiscence at proximal border. The patient was hospitalized and administered antibiotic treatment. A hematoma evacuation was performed. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.
 
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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 Key12668653
MDR Text Key281529033
Report Number3005619263-2021-00033
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/20/2021 Patient Sequence Number: 1
Treatment
3830 LEAD, UNKNOWN LEAD
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