MAUDE Adverse Event Report: ST. JUDE MEDICAL TENDRIL SDX; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1488TC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On (b)(6) 2011 it was reported every time she does isometrics or pocket manipulation, ap/ vp, then on atrial channel there's another signal, not marked by device, about 100 ms after vp.Every now and then, she has a huge pac, but cannot measure p wave.Last p wave was measured in (b)(6) at 4 mv.On (b)(6), stored event for vf with noise on both channels.Patient had pneumonia in (b)(6), with lots of coughing.Tested for underlying at doi 40, and pt still had apnp.No further information available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TENDRIL SDX
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535563
• MDR Text Key: 321519467
• Report Number: MW5142459
• 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: 09/01/2011

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: 1488TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1