MAUDE Adverse Event Report: BIOTRONIK LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number BIOTRONIK LINOX SMART SD 65/16

Device Problems Impedance Problem (2950); Protective Measures Problem (3015)

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

Event Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported that the patient has a biotronic lead implanted (b)(6) 2015.There is a rv lead integrity warning to review high rate non-sustained episodes, sensing integrity counter (sic), and rv lead impedance.The rv lead remains in use.No patient complications have been reported as a result of this event.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17488918
• MDR Text Key: 320695313
• Report Number: MW5121617
• Device Sequence Number: 1
• Product Code: NVY
• 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: 01/24/2023

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: BIOTRONIK LINOX SMART SD 65/16
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1