MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number	24970A
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported an error message appeared during implant indicating the programmed value or programmed mode could not be accepted and to exit the pop-up box and select a new parameter.This occurred after the user tried to assess lv (left ventricular) lead placement, while testing lv tip to ring configuration.As a result, a pacing mode or rate to analyze the lead could not be set.The user then exited the pop-up and tried to re-select, but the system locked, would not allow them to advance, and wouldn't launch after.The application was forced closed, and the base station power was disconnected and reconnected, which did not work.Finally, a soft reset of the tablet worked.A different programmer/analyzer model was used to finish the case.The mobile programmer application remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Analysis summary: the reported out of specification issues with the mobile programmer application were confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported an error message appeared during implant indicating the programmed value or programmed mode could not be accepted and to exit the pop-up box and select a new parameter.This occurred after the user tried to assess lv (left ventricular) lead placement, while testing lv tip to ring configuration.As a result, a pacing mode or rate to analyze the lead could not be set.The user then exited the pop-up and tried to re-select, but the system locked, would not allow them to advance, and wouldn't launch after.The application was forced closed, and the base station power was disconnected and reconnected, which did not work.Finally, a soft reset of the tablet worked.A different programmer/analyzer model was used to finish the case.The mobile programmer application remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK SMARTSYNC
• Common Device Name: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 6780194
• Report Number: 3004593495-2017-00397
• Device Sequence Number: 999711
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163008
• 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,Followup
• Report Date (Section B): 12/07/2017

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: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1