MAUDE Adverse Event Report: MPRI CAPSURE Z; PERMANENT PACEMAKER ELECTRODE

Model Number 553453

Device Problem Impedance Problem (2950)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: w2dr01 ipg; implant date: (b)(6) 2023 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the right ventricular (rv) lead exhibited high impedance and also polarity switch.It was further reported that the ra lead exhibited variable impedance.The rv and ra lead remains in use. no patient complications have been reported as a result of this event.

• Brand Name: CAPSURE Z
• Type of Device: 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: 19002983
• MDR Text Key: 338945700
• Report Number: 2649622-2024-08658
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P850089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 553453
• Device Catalogue Number: 553453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 503458 LEAD
• Patient Sex: Male