MAUDE Adverse Event Report: MEDTRONIC DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 4076

Device Problem Material Twisted/Bent (2981)

Patient Problem Bradycardia (1751)

Event Date 10/08/2012

Event Type  Injury  

Event Description

Patient called in to patient services on (b)(6) 2012.She was just in (b)(6) hospital in providence a couple of weeks ago and had to see her ihcp because her heart rate was down to 45-48 8pm.They told her she had a twisted wire which might have occurred at night because she says she doesnt touch the thing.She said (b)(6) was her implanter but she is followed by dr.(b)(6) instead.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17520651
• MDR Text Key: 321045447
• Report Number: MW5127599
• Device Sequence Number: 1
• Product Code: NVN
• 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: 11/13/2012

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: 4076
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1