MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problems Loss of Power (1475); Failure to Power Up (1476); Operating System Becomes Nonfunctional (2996); Noise, Audible (3273)

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

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while measuring electrograms through an implantable heart device the programmer stopped working.Subsequently, whenever the programmer was attempted to be switched on it would not come on and a humming noise would emit from the box near the ac power supply cable.The programmer has not been received into service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: analysis was unable to confirm the stated reason for return that the programmer stopped working and would no longer power up normally, it started up normally and performed a device interrogation with no observations noted as well as performing incoming testing with no observations.A new software reconfiguration was performed to eliminate possible software errors.It was additionally noted that the power cord bay door was damaged, that there were errors in the update history and that the bezel had minor damage (considered acceptable).The power cord bay was replaced, the touch screen was calibrated, new software was installed and the device was cleaned.It then passed its electrical safety as well as all final functional and systems tests.Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the product had been returned to service.

Manufacturer Narrative

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

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7732058
• MDR Text Key: 115566809
• Report Number: 2182208-2018-01378
• Device Sequence Number: 1
• Product Code: KRG
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 08/08/2018
• Supplement Dates FDA Received: 09/04/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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