MAUDE Adverse Event Report: MPRI SCREW-IN LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5071-25
Medical Device Problem Codes	Break (1069); Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited high thresholds leading to non capture.This resulted in higher drainage on the battery on the implantable pulse generator (ipg), resulting in unexpected battery longevity.The rv lead also exhibited high thresholds and non capture when the settings of the ipg reactivated it.  during the change out procedure, the pacing leads were damaged and were partially removed and replaced.The ipg was explanted and replaced.The ipg set to pace ra lead only and have the rv lead inactive until required.Temporary pacing was required during the generator procedure. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Concomitant medical products:w1dr01 ipg implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SCREW-IN LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 13341178
• Report Number: 2649622-2022-01700
• Device Sequence Number: 17168960
• Product Code: DTB
• UDI-Device Identifier: 00681490124300
• UDI-Public: 00681490124300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• 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): 01/25/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/08/2003
• Device Model Number: 5071-25
• Device Catalogue Number: 5071-25
• 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: 01/10/2022
• Initial Report FDA Received Date: 01/25/2022
• 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: 4968-35 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 55 KG