• 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 Problem Unspecified Infection (1930)
Event Date 05/20/2021
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: 5076-45 lead, implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that six days post cardiac resynchronization therapy defibrillator (crt-d) implant with an antibacterial absorbable envelope, the patient was admitted due to an infection. The right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead were explanted. The crt-d and a temporary rv lead were used temporarily until the patient received a new implantable cardioverter defibrillator (icd) system four days later. 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
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 Key11999976
MDR Text Key256220907
Report Number2182208-2021-02415
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,Followup
Report Date 07/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2021
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
Device LOT NumberR142085
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 Received07/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/27/2021
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: 06/15/2021 Patient Sequence Number: 1
Treatment
DTPA2QQ CRT-D, 6935M55 LEAD, 479888 LEAD
-
-