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

Model Number 2067L

Device Problem Communication or Transmission Problem (2896)

Patient Problem Dizziness (2194)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event 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
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7417276
• MDR Text Key: 105100525
• Report Number: 2182208-2018-00542
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902290138
• UDI-Public: 00721902290138
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Date Device Manufactured: 01/31/2005
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 88 YR