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

Model Number 5392

Device Problems Failure to Capture (1081); Nonstandard Device (1420); Connection Problem (2900)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed one cable was broken.It was noted fastlock is a non medtronic cable.Analysis could not confirm device malfunction at other settings, modes, or capture.Analysis found the lower case battery compartment cover screw was rusted.(b)(4).

Event Description

It was reported the epg (external pulse generator) has a broken fastlock connector attached to the atrial connection.The fastlock got broken during the time when the patient was being moved and only the ventricle part was used.It was also reported there was a code blue and cpr (cardiopulmonary resuscitation) had begun.The patient did not have iv (intravenous) access.An icu (intensive care unit) nurse placed a piv (peripheral intravenous) in the left hand and another provider placed an io (intraosseous) in the right leg.A medicine resident was running the code.The patient appeared to be somewhat alert and moving.It was attempted to open the mouth to attempt intubation however the patient's muscular tone was very strong.Cpr was continued.On the first defibrillation attempt the patient responded "ouch".The patient was still pulseless following defib, epi, amio, etc.The patient was in vt/vf (ventricular tachycardia/ventricular fibrillation) according to the medicine resident running the code.The patient was eventually intubated using etomitate.After 15-20 minutes of cpr, the epg was looked at.The epg was set at ddd 200 (rate of 200, atrial 25 milliamp, ventricular 25 milliamp).The atrial lead was disconnected from the epg.The epg rate was turned down to 100.The epg was not capturing at this point and the atrial wire appeared to have been cut.A rn (registered nurse) in the room stated that during transport the atrial wire had been severed and that the last time the rn saw the epg, it was set at vvi@40.The epg was set at 200.Clinical event note from the medicine resident running the code stated that the rhythm was vt in 200s when the code began.The epg was returned for general evaluation, test, and calibration.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5278390
• MDR Text Key: 33051071
• Report Number: 3004593495-2015-00343
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: 10/08/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1356-2015
• Patient Sequence Number: 1