MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. CARELINK; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-PROGRAMMER

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

Patient Problem Atrial Flutter (1730)

Event Date 07/17/2014

Event Type  Injury  

Event Description

It was reported that the patient goes into an atrial flutter rhythm during device interrogation and that this was possibly due to asynchronous pacing at the beginning of the interrogation.This only occurs with in-office interrogation and not during remote monitor transmission.Troubleshooting attempts have been made related to software application and timing of programmer head placement during interrogation.The device remains in use.Further actions will be evaluated.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.Concomitant medical products: 2067 rf head; hc15018 tissue valve implanted: (b)(6) 2011.(b)(4).

• Brand Name: CARELINK
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 372
• 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: 4006737
• MDR Text Key: 4954494
• Report Number: 2183613-2014-01129
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-PROGRAMMER
• Device Catalogue Number: MDT-PROGRAMMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/13/2014
• 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: ADDR01 IPG, 4968-35 LEAD, 4968-35 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 00005 YR