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

Model Number 5392

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

It was reported that after purchasing a new external pulse generator (epg) an initial check was performed before putting the device into hospital circulation.It was noted that there was no electrical contact when using energizer aa batteries in the epg, the epg would not turn on.Energizer is the contracted supplier for this hospital which means this is the only battery brand used in the hospital.The negative end of the battery does not extend as far as other aa batteries.About 50% of the time, the epg did not turn on after having introduced the aa energizer batteries due to loss of or no contact with the battery terminal.The hospital will not be using this device unless a solution is found.The status of the epg is unknown.There was no patient involvement reported.

Manufacturer Narrative

This event occurred outside the u.S where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the device was not returned, the only hardware items received were the batteries.Visual inspection showed no signs of damage, the negative terminals have dimples, the dimples appear to have been present as originally manufactured.The battery voltages were measured.The batteries measured 1.555v and 1.557v.This indicates that the batteries were new and had sufficient voltage to be used in the 5392 device.The batteries were installed in an engineering 5392 device.The device was powered on and functioned normally.The battery positions were then swapped and the 5392 would not power on.It was observed that the dimple in the negative battery terminal aligns with the 5392 shorting bar/contact point.The battery drawer was opened and closed with the batteries installed in the orientation that previously did not allow the device to power on.After opening and closing the drawer, the device successfully powered on.The device was then bumped on the side and the low battery led came on, indicating that the battery had lost contact.After the battery backup time elapsed, the device shutdown.Conclusion: it was confirmed that the batteries that were returned did not make reliable contact in an engineering device.(b)(4).

Manufacturer Narrative

The epg involved with the event was later returned to the manufacturer.Visual inspection revealed no anomalies.Further analysis verified that the device did not power up with the batteries that were sent back.Measurement of the shorting bar in the battery compartment showed that the shorting bar was in specification.Conclusion: the device was not compatible with the returned lr6 batteries.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 1190 0; 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: 4162420
• MDR Text Key: 4789979
• Report Number: 3004593495-2014-00041
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• 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: 10/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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