MAUDE Adverse Event Report: MEDTRONIC BIVENTRICULAR ICD; PULSE GENERATOR PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION CCRT-P

Device Problems Device Dislodged or Dislocated (2923); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2018

Event Type  malfunction  

Event Description

Pt underwent biventricular icd implantation.Device interrogation revealed possible atrial lead dislodgement.Pt returned to cath lab the next day and found that the atrial lead was dislodged and was malfunctioning.

• Brand Name: BIVENTRICULAR ICD
• Type of Device: PULSE GENERATOR PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION CCRT-P
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 8270747
• MDR Text Key: 134071578
• Report Number: MW5083280
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR