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U.S. Department of Health and Human Services

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

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PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION Back to Search Results
Model Number 24970A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the connectivity between the programmer patient connector and the implantable device was lost during an active session. At the time, pending parameters were being programmed into the patient information page on the implantable device. The device connection indicator on the patient connector was solid amber. Several minutes passed without reconnection. The session was ended, the application was closed, and all connections were restarted. No further connectivity issues were noted. The programmer remains in use. There was no patient involvement.

 
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Brand NameCARELINK SMARTSYNC BASE
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8629459
MDR Text Key145691549
Report Number3004593495-2019-00476
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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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