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

Model Number 2090

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926); Operating System Becomes Nonfunctional (2996); Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Event Description

It was reported that the programmer could not be updated, and experienced a telemetry defect.It was further reported that the programmer crashed during update.The programmer was returned for service.It was determined on analysis that the programmer which returned for service subsequently tested out of specification during manufacturer's assessment.There was no patient involvement.

Manufacturer Narrative

Product analysis: it was determined on analysis that the programmer tested out of specification due to the link electronic module board causing a short circuit preventing the power supply from starting up.It was also noted that analysis partially confirmed the customer's comment that the programmer crashed during an update as the micro processor unit could not handle the 20 gigabit universal serial bus media key that was used to attempt to downgrade the programmer software.Software errors were noted in the software history log.The touch screen bezel was broken / cracked.The paper tray was broken.Paper was jammed in the printer tray.The cord bay and both latches were broken.Both keyboard hinges were broken.Anti-slip layer of the radiofrequency head was worn.The lower casing of the programmer was cracked near the carrying handle.It was recommended that the programmer be decommissioned and was done with approval of the customer.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK PROGRAMMER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12796163
• MDR Text Key: 280692632
• Report Number: 2182208-2021-04456
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2021

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: 06/03/2021
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2002
• 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