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	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2021; 5071-53 lead, implanted: (b)(4) 2022.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to hospital with possible incision issues one month after the implantable cardioverter de fibrillator (icd) system was implanted.Upon testing and x-ray, the right ventricular (rv) lead had dislodged into the atrium and the epicardial lead incision was ¿oozing¿.During rv lead reposition, when the physician opened the device pocket, it appeared to be infected.The physician decided to remove the icd system.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: 13969167
• Report Number: 2649622-2022-06093
• Device Sequence Number: 4176563
• Product Code: DTD
• UDI-Device Identifier: 00613994500298
• UDI-Public: 00613994500298
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K911048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/31/2022

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: 06/17/2025
• Device Model Number: 5867-3M
• Device Catalogue Number: 5867-3M
• Device Lot Number: VA2F1X3
• 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: 03/15/2022
• Initial Report FDA Received Date: 03/31/2022
• Date Device Manufactured: 06/21/2021
• 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: 6725 ADAPTOR, 6935M62 LEAD, DTMA1D4 ICD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 127 KG