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

Model Number	24970A
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Pacing Problem (1439)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
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 that during right ventricular (rv) lead testing for an implantable pulse generator (ipg) changeout, on a patient with complete heart block, there was a delay in pacing.While doing sensing measurements, and increasing the rate to 70 beats per minute (bpm), there was a delay (hour glass), then once it went to 70 bpm, there was a delay (hour glass) before pacing resumed.The patient had a heart rate that consistently came in around 30 bpm.In addition, while generating reports, the entire application locked up and had to be shut down twice.Following the second time of shutting down and re-booting, the keyboard would pop up on every screen including the threshold screen and between threshold decrements.It was unusable and had to be re-booted again.After this third time, it seemed to work at baseline level.The mobile programmer application remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the reported out of specification issue with the mobile programmer application was confirmed.If information is provided in the future, a supplemental report will be issued.

• 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: 6780181
• Report Number: 3004593495-2017-00398
• Device Sequence Number: 920055
• 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): 08/10/2017

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: 06/09/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1