MAUDE Adverse Event Report: MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER

Model Number 229047

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917); Output Problem (3005)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when the analyzer was connected to the measurement cable in the ventricular channel, the r wave was not sensed, and the impedance measurement showed above 400 ohms.The atrial channel was then verified, and sensed wave value was displayed, and the impedance was as expected.The analyzer cable was changed but this failed to improve the issue.The analyzer was then changed out for an alternative and the case could then be completed.No patient complications have been reported as a result of this event.

• Brand Name: PACING SYSTEM ANALYZER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10875019
• MDR Text Key: 217338976
• Report Number: 2182208-2020-02911
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902256011
• UDI-Public: 00721902256011
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229047
• Device Catalogue Number: 229047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1