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

Model Number 229003

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: it was determined at analysis that the analyzer tested out of electrical specification, the device failed incoming test functional tests.The analyzer was replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the electrocardiogram (ecg) port of a programmer was defective.The analyzer was returned as an associated device.No patient involvement was reported.It was further reported that the analyzer subsequently tested out of specification during manufacturer's analysis.

• 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: 10244012
• MDR Text Key: 197923773
• Report Number: 2182208-2020-01230
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229003
• Device Catalogue Number: 229003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2010
• 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
• Treatment: PRGM 2090 PROGRAMMER