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

Model Number	NMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	09/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product - model: 39565-65, pain stim lead; implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post a implantable neurological stimulator (ins) changeout procedure the patient developed redness around the ins pocket site along with cellulitis.The patient was admitted to the hospital and antibiotic treatment was started for a possible infection.It was indicted that a antibacterial absorbable envelope was implanted with the ins device at the changeout procedure.The device and envelope remain implanted and in use.No further patient complications have been reported as a result of this event.

• Brand Name: TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9124706
• Report Number: 2182208-2019-01743
• Device Sequence Number: 2332646
• Product Code: FTL
• UDI-Device Identifier: 00763000101626
• UDI-Public: 00763000101626
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 10/31/2019
• Device Model Number: NMRM6122
• Device Catalogue Number: NMRM6122
• Device Lot Number: R117701R21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/26/2019
• 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: 97715, IMPLANTABLE NEUROLOGICAL STIMULATOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR