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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

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PLEXUS MANUFACTURING SDN. BHD DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 5392
Device Problems Intermittent Capture (1080); Failure to Capture (1081); Under-Sensing (1661); Unexpected Shutdown (4019)
Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418); R On T Phenomenon (3163)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the external pulse generator (epg) turned off during use with a patient after which the patient went asystolic.The issue was rectified by turning the device back on.It was speculated that the device was changed out.It is expected the device will be returned for evaluation.No further patient complications were reported.It was further reported that the patient was becoming unresponsive after going asystolic and experienced ventricular standstill (only p waves displayed on screen).As a result the epg was rebooted which restarted the pacing leading to the patient regaining consciousness.It was also noted that the epg experienced intermittent episodes of failing to sense, failing to capture and r on t issues.Instructions were given to adjust the parameters of the device as a precaution.
 
Manufacturer Narrative
Product analysis: analysis was unable to confirm the customer comment of a device shut down whilst in use.Analysis also noted that the hanger assembly was broken, error 820 occurred on two occasions and the main printed circuit board was out of electrical specification.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 further reported that the patient was becoming unresponsive after going asystolic and experienced ventricular standstill (only p waves displayed on screen).As a result the epg was rebooted which restarted the pacing leading to the patient regaining consciousness.It was also noted that the epg experienced intermittent episodes of failing to sense, failing to capture and r on t issues.Instructions were given to adjust the parameters of the device as a precaution.It was further reported that the device was returned for service.
 
Manufacturer Narrative
Corrections: h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
 
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Brand Name
DUAL CHAMBER TEMPORARY PACEMAKER
Type of Device
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY  11900
MDR Report Key10049711
MDR Text Key190746388
Report Number3004593495-2020-00533
Device Sequence Number1
Product Code DTE
UDI-Device Identifier00643169725126
UDI-Public00643169725126
Combination Product (y/n)N
PMA/PMN Number
K150246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5392
Device Catalogue Number5392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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