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

Model Number	2067L
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that at the end of a ventricular threshold test, the programmer's stylus pen was lifted off the screen but instead of immediately returning to programmed parameters, the testing parameters remained for several seconds causing extended loss of capture.The patient became symptomatic and lightheaded and was steadied as the programmed outputs resumed.It was indicated that it was a probability that the telemetry link between the radiofrequency head and the device was interrupted and the end command for the threshold test was delayed.The programmer and radiofrequency head remain in use.No further 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: 7417276
• Report Number: 2182208-2018-00542
• Device Sequence Number: 13692937
• Product Code: KRG
• UDI-Device Identifier: 00721902290138
• UDI-Public: 00721902290138
• 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): 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 88 YR