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

Model Number MDT-POWER-CORD

Device Problem Material Frayed (1262)

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

Event Date 12/11/2009

Event Type  malfunction  

Event Description

It was reported that the programmer power cord was frayed.The power cord was returned to the manufacturer.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event was assessed and is being reported as a part of a retrospective review of events, which was in response to mdr criteria revisions and on-going process improvements.Product event summary: analysis could not confirm the reported event, no fault was found with device.(b)(4).

• 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: 4609765
• MDR Text Key: 19359790
• Report Number: 2182208-2015-00761
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MDT-POWER-CORD
• Device Catalogue Number: MDT-POWER-CORD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2009
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2009
• Was Device Evaluated by Manufacturer?: Yes
• 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: 2290 ANALYZER