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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 Problems Display or Visual Feedback Problem (1184); Reset Problem (3019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
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 mobile programmer was in use during an implant procedure when a implantable pulse generator (ipg) exhibited a device reset. The reason for reset was unknown. It was further noted that the patient was undergoing an ipg change procedure when the user proceeded to perform device based testing with the mobile programmer which was already connected to the implanted device via a bluetooth connection. When the user initiated the lead impedance test, the programmer immediately gave a message that "the ipg had undergone an electrical reset, battery voltage was unavailable though the programmed device parameters were unchanged". The user then cleared the device reset and proceeded with further device testing and final programming. The "remaining longevity" gauge displayed greyed-out and indicated "pre-implant". The mobile programmer remains in use. No patient complications have been reported as a result of this event.

 
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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 Key10464377
MDR Text Key204682540
Report Number3004593495-2020-00976
Device Sequence Number1
Product Code DTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2020
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 Received10/04/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/02/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/28/2020 Patient Sequence Number: 1
Treatment
W1DR01,
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