MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 2490C15

Device Problem Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

It was reported that the device had fast depletion.During follow up the battery was already at 2.67v (volts) while the implantable cardioverter defibrillator (icd) delivered only one shock and there was minimal pacing.Technical services (ts) indicated that the battery trend indicated an issue with the remote monitor.No information was available regarding the monitor and it was suggested that it may be unplugged and needed to wait until the next patient follow up.Both the icd and monitor are still in use.The patient will be followed normally.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: analysis found contamination at rf antenna bottom housing, top and bottom housing.Bench power up test failed.Printed circuit board assembly contamination caused the unit to be unable to power up.The tester is able to simulate the failure.It could not be determined what caused the fluid ingress.

• Brand Name: CARELINK
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 3993698
• MDR Text Key: 4780013
• Report Number: 3004593495-2014-00029
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2490C15
• Device Catalogue Number: 2490C15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1