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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 Hematoma (1884); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Event Date 02/24/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that approximately ten days post replacement procedure of a cardiac resynchronization therapy pacemaker (crt-p) with an antibacterial absorbable envelope, the patient developed a possible infection. It was noted that the patient presented with severe pain, swelling, and bruising at the crt-p site. The patient white blood cell count was low but no other signs of infection. The physician decided to do a hematoma evacuation and obtain cultures. An additional antibacterial absorbable envelope was used during the hematoma evacuation. 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 Key11516423
MDR Text Key240660152
Report Number2182208-2021-01089
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,Followup
Report Date 04/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCMRM6122
Device Catalogue NumberCMRM6122
Device LOT NumberR138529
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 Received03/18/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/22/2020
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: 03/18/2021 Patient Sequence Number: 1
Treatment
W4TR01 CRTP, 479888 LEAD, 5076-58 LEAD
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