MAUDE Adverse Event Report: ST. JUDE ST. JUDE; PACEMAKER PULSE GENERATOR

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 08/20/2015

Event Type  Injury  

Event Description

Pt undergoing elective replacement of pacemaker.Physician using plasma blade to dissect the pocket and touched the generator with blade.Pulse generator became non functioning and pt experienced asystole.External pacing initiated while new generator was placed.There was no permanent harm to pt.

• Brand Name: ST. JUDE
• Type of Device: PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE ; st. paul MN
• MDR Report Key: 5080795
• MDR Text Key: 26007386
• Report Number: MW5056187
• Device Sequence Number: 1
• Product Code: DXY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: 5826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR