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

Model Number 2292

Device Problem Pacing Problem (1439)

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

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that the analyzer had programmed automatically amplitude and pulse-width to maximum value on the atrial channel and no sensing on the atrial channel.In addition the measurement cable was changed.The analyzer was returned to the manufacturer for servicing.The cable is still in use.No patient complications have been reported as a result of this event.

• Brand Name: ANALYZER CABLE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5283419
• MDR Text Key: 33528962
• Report Number: 2182208-2015-04643
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/22/2015

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: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2015
• Initial Date FDA Received: 12/09/2015
• 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