MAUDE Adverse Event Report: MPRI LEAD END CAP KIT; PACEMAKER LEAD ADAPTOR

Model Number	5867-3M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 5076-52 lead, implanted: (b)(6) 2015; 5076-45 lead, implanted: (b)(6) 2015; a2dr01 ipg, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced an infection.The entire pacing system was explanted and replaced with a leadless implantable pulse generator (ipg).Antibiotic treatment was administered. no further patient complications have been reported as a result of this event.

• Brand Name: LEAD END CAP KIT
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12909924
• Report Number: 2649622-2021-23898
• Device Sequence Number: 4884517
• Product Code: DTD
• UDI-Device Identifier: 00613994500298
• UDI-Public: 00613994500298
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K911048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 08/30/2021
• Device Model Number: 5867-3M
• Device Catalogue Number: 5867-3M
• Device Lot Number: VA1KDAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/01/2021
• Date Device Manufactured: 09/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W1DR01 IPG, 5076-58 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 86 KG