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

Model Number R2290

Device Problems Over-Sensing (1438); Capturing Problem (2891); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the analyzer gave "abnormal results".The right ventricular (rv) threshold captured even at the lowest setting: 0.1 volts @ 0.02ms.The analyzer was returned for service.No patient complications have been reported as a result of this event.It was further reported that, at implant, the user was able to assess the rv threshold by adjusting the pulse width.

Manufacturer Narrative

Product analysis: analysis was unable to confirm customer comment that the analyzer gave abnormal results and was oversensing because testing of the device was not possible due to a damaged patient connector.The analyzer was replaced and the replacement passed all final functional and systems tests.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACING SYSTEM ANALYZER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9779914
• MDR Text Key: 186835089
• Report Number: 2182208-2020-00418
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902710322
• UDI-Public: 00721902710322
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R2290
• Device Catalogue Number: R2290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 59