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

Model Number 2090

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2013

Event Type  malfunction  

Event Description

It was reported that despite trying multiple cables, an ecg (electrocardiogram) signal could not be obtained.The programmer was re turned for repair, test/calibration, and update.There was no patient involvement.

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 was unable to confirm the customer comment that an electrocardiogram (ecg) signal could not be obtained, however analysis did find that some ecg lead cables were not seated in the collector cable.It was also noted that ecg lead select and gain tests, ecg low pass filters test, the ecg high pass filter test and the artifact signal test were all out of specification and therefore the link electronic module board was replaced.Analysis also found that the printer switch was worn out, that the display had a distortion in the lower bottom of the screen, that there was a cracked upper hinge plate and a damaged printer, and therefore all were replaced.(b)(4).

• 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 CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3613837
• MDR Text Key: 4066911
• Report Number: 2182208-2014-00090
• 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: 11/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• 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: 11/15/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2003
• 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
• Treatment: 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD