MAUDE Adverse Event Report: ABBOTT MEDICAL TENDRIL SDX LEADS; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1488T, 1488T

Device Problem Migration (4003)

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

Event Type  malfunction  

Event Description

Patient stated she had a mammogram done a while ago and the image shows two leads slicking out of her pacemaker.Patient stated they are old leads and i dont think they are working right.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL SDX LEADS
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17540295
• MDR Text Key: 321268430
• Report Number: MW5144512
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1488T, 1488T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Patient Sequence Number: 1