MAUDE Adverse Event Report: BIOTRONIK LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 350054

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877); Battery Problem (2885); Impedance Problem (2950)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter-"defibrillator" (icd) delivered some electric shocks.It was suspected that this patient was in sinus rhythm.Technical services (ts) was consulted and provided troubleshooting suggestions.The icd tried to be interrogated.Unfortunately, it was found that the remote monitoring capabilities had become disabled due to limited battery capacity once the icd reached the end of life (eol).Further review of this icd data revealed that anti-tachycardia pacing (atp) therapy was delivered to convert the arrhythmia.Additionally, out-of-range pacing impedance measurements, out-of-range shock impedance measurements, and noisy signals were also observed.Ico system replacement was recommended.Subsequently, a revision procedure was performed and the icd and the non-boston scientific lead were explanted and replaced.No additional adverse patient effects were reported.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: 17528475
• MDR Text Key: 321081893
• Report Number: MW5135405
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 350054
• Device Lot Number: 10299114
• Patient Sequence Number: 1