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

Model Number 2090

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed the customer comment that the stylus did not align with the cursor on the display screen of the device; the bezel shield assembly was replaced and the stylus was re-calibrated to the touch screen.The display screen had a big white spot on the bottom left corner.The device also had a broken left keyboard hinge, broken latch tab on the power cord bay, a noisy power supply, and a missing foot on the lower case.All found defective or missing parts were replaced.The link electronic module (lem) board was also replaced due to an error, and the hard drive was reconfigured, reloaded, and the software updated.The device passed final functional and systems tests.No other anomalies were found.(b)(4).

Event Description

It was reported that the programmer stylus pen was inaccurate after calibrating.It was noted that the issue seemed to be worse on the lower part of the display.Multiple pens were attempted with no resolution of the issue.The programmer was returned for repair and test and calibration.There was no patient involvement.

• 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: 5559246
• MDR Text Key: 42695107
• Report Number: 2182208-2016-01022
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2016

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: 02/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2011
• 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