MAUDE Adverse Event Report: MEDTRONIC, INC. AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model: 5867-3m, lead end cap kit; implanted: (b)(6) 2019.Model: 5076-58, lead; implanted: (b)(6) 2019.Model: ddmb1d1, implantable cardioverter defibrillator (icd); implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that approximately sixty days post a lead revision procedure the patients implantable cardioverter defibrillator (icd) had eroded to the surface of the skin.It was noted that at the time of the revision a antibacterial absorbable envelope was implanted.The icd system and leads have been extracted.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the patient had developed a local infection in addition to the erosion.No further patient complications have been reported as a result of this event.

• Brand Name: AIGIS-R MEDIUM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8591143
• Report Number: 2182208-2019-00857
• Device Sequence Number: 2193044
• Product Code: FTL
• UDI-Device Identifier: 00763000101602
• UDI-Public: 00763000101602
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R109620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 694765, LEAD / 407652, LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR