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

Model Number	5071-15
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated oversensing due to electromagnetic interference/noise.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the implantable pulse generator (ipg) had a loose set screw that caused right ventricular (rv) lead oversensing of noise and high and undefined impedance.It was also reported that the rv lead had fractured.The ipg and rv lead were inactivated and replaced. no patient complications have been reported as a result of this event.

• 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: 12779475
• Report Number: 2649622-2021-22322
• Device Sequence Number: 7045817
• Product Code: DTB
• UDI-Device Identifier: 00681490124225
• UDI-Public: 00681490124225
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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): 11/09/2021

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: Lay User/Patient
• Device Expiration Date: 04/14/2009
• Device Model Number: 5071-15
• Device Catalogue Number: 5071-15
• 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: 10/20/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2005
• 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: W1SR01 IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 39 KG