MAUDE Adverse Event Report: PACEMAKER; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Pt reported that he went to the hospital due to a pacemaker and was admitted.Pt also started a new medication minocycline for acne no add'l info noted.Pt does not consent to be contacted.Reporter doesn't consent for manufacturer follow up.

• Brand Name: PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• MDR Report Key: 16552553
• MDR Text Key: 311490516
• Report Number: MW5115778
• Device Sequence Number: 1
• Product Code: LWP
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: COSENTYX; MINOCYCLE
• Patient Age: 48 YR
• Patient Sex: Male