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

Model Number	5867-3M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an implant procedure, after tunneling over the sternum from right to left to allow the lead to be connected to the left sided device, the lead had gotten 'folded' so the tip was moving through the tunnel backwards.The cap that was temporarily secured with sutures to the lead pin for the duration of the procedure had pulled off and was missing from the tip of the lead.The lead was functioning as expected so the decision was made to leave the cap in the patient.

• 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: 12894535
• Report Number: 2649622-2021-23776
• Device Sequence Number: 3888443
• Product Code: DTD
• UDI-Device Identifier: 00763000059460
• UDI-Public: 00763000059460
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K911048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2025
• Device Model Number: 5867-3M
• Device Catalogue Number: 5867-3M
• Device Lot Number: VA2EZPV
• 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: 11/24/2021
• Initial Report FDA Received Date: 11/30/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male