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

Model Number	2067
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was unable to confirm customer comment.Radiofrequency head had green light, and was able to interrogate devices using a known good programmer.However, the radiofrequency head had fog inside upper case lens.Also, found corrosion inside radiofrequency head.The radiofrequency head failed e-field immunity test.The radiofrequency head was scrapped at service department.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the radiofrequency head was unable to light green and was unable to interrogate devices.The radiofrequency head was returned for service.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7101685
• Report Number: 2182208-2017-02194
• Device Sequence Number: 13735915
• Product Code: KRG
• UDI-Device Identifier: 00721902290121
• UDI-Public: 00721902290121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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
• Operator of Device: Other
• Device Model Number: 2067
• Device Catalogue Number: 2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1