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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 Use of Device Problem (1670)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 407645 lead, implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that while closing the pocket at the end of the implant procedure, the physician noted that the right ventricular (rv) lead thresholds had risen and ectopy was observed. It was determined that the rv lead and the left ventricular (lv) lead had dislodged due to the rv being sewn to the antibacterial absorbable envelope and the muscle. The rv lead was also exhibiting no capture. Repositioning of the rv lead was attempted but unsuccessful, so the rv lead was capped and replaced. The lv lead was explanted and replaced. The antibacterial absorbable envelope remains in the patient. 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 Key11619385
MDR Text Key243943905
Report Number2182208-2021-01341
Device Sequence Number1
Product Code FTL
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberCMRM6133
Device Catalogue NumberCMRM6133
Device Lot NumberR128775
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 Received03/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/20/2020
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: 04/06/2021 Patient Sequence Number: 1
Treatment
6935M55 LEAD, 479888 LEAD, DTMA1QQ CRT-D
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