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U.S. Department of Health and Human Services

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

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Pacing Problem (1439)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2017
Event Type  Malfunction  
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 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.

 
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.

 
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Brand NameCARELINK SMARTSYNC
Type of DeviceANALYZER, PACEMAKER GENERATOR FUNCTION
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer (Section G)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY 11900
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6780181
MDR Text Key82592119
Report Number3004593495-2017-00398
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24970A
Device Catalogue Number24970A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/22/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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