MAUDE Adverse Event Report: ABBOTT MEDICAL / ST. JUDE MEDICAL PACEMAKER; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2240

Device Problems Ambient Noise Problem (2877); Moisture or Humidity Problem (2986)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  Injury  

Event Description

In the setting of increasing burden of atrial and rv (residual volume) lead noise with device, on advisory for potential moisture buildup on the header.So generator was changed (b)(6) 2022.

• Brand Name: PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL / ST. JUDE MEDICAL
• MDR Report Key: 15754569
• MDR Text Key: 303393240
• Report Number: MW5113141
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Race: Black Or African American