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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 Use of Device Problem (1670)
Patient Problem Unspecified Infection (1930)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 479888 lead, implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient, who had a cardiac resynchronization therapy pacemaker (crt-p) system that was implanted with a antibacterial absorbable envelope, came to the clinic with what appeared to be cellulitis adjacent to the crt-p pocket. The patient was given antibiotics and the cellulitis cleared after several days. The crt-p system remains 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 Key10460717
MDR Text Key204576912
Report Number2182208-2020-01660
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130943
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 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR127917
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 Received08/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2020
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: 08/27/2020 Patient Sequence Number: 1
Treatment
W4TR02 CRT-P, 5076-52 LEAD, 5076-58 LEAD
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