• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Swelling/ Edema (4577)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: dtma1qq 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 may be experiencing an allergic reaction to their cardiac resynchronization therapy defibrillator ( crt-d) system due to repeated wound dehiscence. It was later reported that the patient was receiving antibiotic intravenous (iv) treatment for an infection. The crt-d system remains in use. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12342560
MDR Text Key267272867
Report Number3005619263-2021-00024
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/08/2022
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR145315
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 Received08/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/13/2021
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: 08/19/2021 Patient Sequence Number: 1
Treatment
383059 LEAD, 6947M55 LEAD, 459888 LEAD
-
-