MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC LEAD; PACEMAKER LEAD ADAPTER

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/26/2018

Event Type  Injury  

Event Description

Around 4 am on (b)(6) 2018, i was hospitalized due to the medtronic lead firing 76 times for no reason.I am now off of work and how to have a hospital stay as well as a lead extraction and lead replacement (b)(6)2018.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PACEMAKER LEAD ADAPTER
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 7654300
• MDR Text Key: 113003874
• Report Number: MW5078176
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR