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

Model Number 2090

Device Problems Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was further reported that during the implant procedure, the programmer was unable to establish telemetry with the implantable cardiac device.It was reported that one bar of telemetry was intermittently displayed on the radiofrequency head of the programmer.The procedure was completed by using an alternative programmer.

Manufacturer Narrative

Product analysis :analysis was able to confirm the customer complaint that the programmer interrogated to device intermittently.The radio frequency (rf) programming head connector on the link electronic module (lem) was loose.The keyboard compartment was contaminated.The power cord bay assembly latches were broken.The programmer was replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer could not connect to or interrogate the implanted device.The programmer was powered down and restarted however the issue persisted.A new radio frequency head was used however was still unsuccessful.The programmer was returned for analysis.No patient complications have been reported as a result of this event.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

Manufacturer Narrative

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: 9765970
• MDR Text Key: 182637198
• Report Number: 2182208-2020-00398
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994581570
• UDI-Public: 00613994581570
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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: 02/12/2020
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2011
• 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
• Patient Age: 83 YR