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

Model Number 1788TC-46

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Observation: atrial lead position check failure.Check atrial lead position.(b)(6) 2020.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL ST
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17534685
• MDR Text Key: 321405877
• Report Number: MW5141585
• 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: 05/03/2021

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: 1788TC-46
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1