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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 Problem Unspecified Infection (1930)
Event Date 07/28/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 4076 lead, implanted: (b)(6) 2016. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient presented to the clinic four days following implant of their device and an antibacterial absorbable envelope due to yellowish liquid leaking from the implant site. There was mild irritation around the implant site; the bandage was changed and the patient was given antiobiotics for seven days. The patient returned for a follow-up approximately three weeks later and the outcome was resolved. The device and envelope remain in use. The patient is a participant in a clinical study. 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 Key11629354
MDR Text Key244260205
Report Number2182208-2021-01363
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK130943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial
Report Date 04/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCMRM6133
Device Catalogue NumberCMRM6133
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 Received09/04/2020
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: 04/07/2021 Patient Sequence Number: 1
Treatment
DTBC2QQ CRT-D, 7122Q LEAD, 4798 LEAD
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