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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 CMRM6133INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Date 12/09/2021
Event Type  Injury  
Event Description
It was reported that approximately seven weeks post replacement procedure, the patient developed a pocket infection.   it was noted that the infection was clearly visual with discharge and the beginning stages of erosion.   the cardiac resynchronization therapy pacemaker (crt-p) system was removed. It was additionally reported that an absorbable antibacterial envelope was originally implanted with the system and it was explanted because of the infection. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13027984
MDR Text Key282482500
Report Number2182208-2021-04967
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMRM6133INT
Device Catalogue NumberCMRM6133INT
Device Lot NumberR148981
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2021
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: 12/17/2021 Patient Sequence Number: 1
Treatment
W1TR04 CRTP, 20066 LEAD
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