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

Model Number 2090

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer¿s stylus was unable to be calibrated.The user was advised on troubleshooting steps, but this failed to resolve the issue.The programmer is expected to be returned for service.There was no patient involvement.

Event Description

It was further reported that the screen would not calibrate to the stylus and it kept shifting in the x/y.It was noted that the product was returned for service.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the programmer's stylus was unable to be calibrated.Reseated connector between xy board and calibrated stylus.It was also noted that the stylus was missing, upper handle and lower handle were broken, there was a broken tab on power cord bay door, left and right display latch hasp were broken and the gasket of media bay and nylon stand off was changed.All found defective parts were replaced and all other identified issues were resolved.Reconfigured hard drive, reloaded and updated software and the device then passed all final functional and systems tests.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10598813
• MDR Text Key: 208922786
• Report Number: 2182208-2020-02117
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994581570
• UDI-Public: 00613994581570
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 11/23/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1