MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE MEDICAL; GENERATOR

Model Number 5356

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Scarring (2061); Complete Heart Block (2627)

Event Date 12/02/2015

Event Type  Injury  

Event Description

Pt with worsening functional status with chronic left bbb, with underlying left heart block.Pacemaker battery with natural depletion over 11 years.Has malfunctioning right atrial lead with removal of the right ventricular lead due to severe scaring and binding to the other lead.The new system pulse generator st.Jude medical (b)(4), serial #(b)(4).Right atrial lead st.Jude medical(b)(4).Right ventricular lead st.Jude medical (b)(4).Left ventricular lead st.Jude medical (b)(4).

• Brand Name: ST. JUDE MEDICAL
• Type of Device: GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 5285436
• MDR Text Key: 33270217
• Report Number: MW5058418
• Device Sequence Number: 2
• Product Code: OAD
• 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: 12/07/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5356
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75