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U.S. Department of Health and Human Services

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

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MEDTRONIC 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 08/05/2022
Event Type  Injury  
Event Description
It was reported that the patient experienced an infection approximately one month after the implant of a cardiac resynchronization therapy defibrillator (crt-d) with an absorbable envelope. It was also noted there was pocket erosion and pus drainage from the pocket. Additionally, the transesophageal echocardiogram (tee) noted vegetations on the leads.  the cardiac resynchronization therapy defibrillator (crt-d) system was explanted.  no further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 5076-52 lead implanted: (b)(6) 2022. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameTYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC
mounds view MN
Manufacturer (Section G)
MEDTRONIC
mounds view MN
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key15305416
MDR Text Key298758825
Report Number2182208-2022-02786
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00763000307882
UDI-Public00763000307882
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR163359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/11/2022
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: 08/26/2022 Patient Sequence Number: 1
Treatment
DTMA1QQ CRT-D, 6935M62 LEAD, 459888 LEAD
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