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

Model Number 2090

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: it was determined on analysis that the touchscreen of the programmer was out of calibration.It was also noted that the left and right cord bay latches were broken.Some screws of the hinge cover plate were missing.Printer paper was almost depleted.The company logo button was broken and errors were identified in software history.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

The programmer was returned and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• 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: 10486845
• MDR Text Key: 205478510
• Report Number: 2182208-2020-01720
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2020

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: 07/21/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2012
• 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