MAUDE Adverse Event Report: BIOTRONIK LINOX; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number LINOXS65

Device Problems Over-Sensing (1438); Protective Measures Problem (3015)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 13:40:02 rv lead integrity warning: 2 or more high rate-ns episodes less than 220 ms.Sensing integrity counter greater than or equal to 30 in 3 days.Unstable thresholds nonphysiologic oversensing suggestive of rv lead integrity issue (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LINOX
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17528039
• MDR Text Key: 321415520
• Report Number: MW5134970
• 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: 08/01/2022

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: LINOXS65
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1