MAUDE Adverse Event Report: MEDTRONIC PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDRL1

Device Problem Positioning Problem (3009)

Patient Problem Twiddlers Syndrome (4563)

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2012 and was explanted on (b)(6) 2013.Patient was a twidder and pulled the leads into the superior vena cava.The physician was unable to reposition the leads because they were knotted up so he cut and capped the remaining portions off and the device was explanted.The physician was (b)(6) at (b)(6) in (b)(6).No other information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17536638
• MDR Text Key: 321268517
• Report Number: MW5143522
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2013

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?: No
• Device Model Number: ADDRL1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1