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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 TYRX-AAE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
Event Date 03/18/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2006 if information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient came into the hospital for pain and burring at the implantable cardioverter defibrillator (icd) site saying it was painful when they moved their arm. Several months alter the patient called in saying that there the device was pinching them, and it feels as if the device might come through their skin. The next day when the patient went into the hospital to have their device checked there was neuropathic pain over top of the device and a severe sharp stabbing pain beneath the device. It was noted that the device was somewhat raised and not flush with the pectorals plane as well as having scabbing over the device site. A pocket revision occurred, and an antibacterial absorbable envelope was implanted. Five weeks after the procedure the patient called in saying there was a ¿red spot with a crusty center on the device site¿ an infection was suspected, and antibiotics were administered. Subsequently the swelling and redness improved. The device remains in use and 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 Key12614725
MDR Text Key275874088
Report Number2182208-2021-04053
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTYRX-AAE
Device Catalogue NumberTYRX-AAE
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 Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/12/2021 Patient Sequence Number: 1
Treatment
DDMB1D4 ICD, 6935M62 LEAD
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