MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 5 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 402657

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 11/18/2018

Event Type  Injury  

Event Description

Ous mdr - device explanted due to noise events sensed on rv lead as ventricular arrhythmias.As a result, the patient received multiple shocks.No adverse events were monitored during last followup with no prior recordings.Due to inappropriate therapy, the crt-d battery decreased significantly to 36% and during the lead extraction procedure the device was replaced as well.

Manufacturer Narrative

The lead and the icd under complaint were returned and thoroughly analyzed.Upon receipt, the icd was interrogated, revealing the battery status mos2.The icd was implanted for 22 months and 116 charging cycles were recorded to the icds memory.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.There was no indication of a device malfunction.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.Subsequently the lead was visually inspected showing multiple signs of wear along the lead body.In particular between 55.5 cm and 57 cm distal to the is-1 connector pin the insulation was found rubbed through.This damage can be considered as the root cause of the reported noise in the right ventricular channel.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the icd functions to be as specified.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.The clinical observation resulted presumably from the leads insulation damage.

Manufacturer Narrative

The correct analysis results are now attached.The lead and the icd under complaint were returned and thoroughly analyzed.Upon receipt, the icd was interrogated, revealing the battery status mos2.The icd was implanted for 22 months and 116 charging cycles were recorded to the icds memory.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.There was no indication of a device malfunction.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.Subsequently the lead was visually inspected showing multiple signs of wear along the lead body.In particular between 55.5 cm and 57 cm distal to the is-1 connector pin the insulation was found rubbed through.This damage can be considered as the root cause of the reported noise in the right ventricular channel.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the icd functions to be as specified.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.The clinical observation resulted presumably from the leads insulation damage.

Event Description

Ous mdr - device explanted due to noise events sensed on rv lead as ventricular arrhythmias.As a result, the patient received multiple shocks.No adverse events were monitored during last followup with no prior recordings.Due to inappropriate therapy, the crt-d battery decreased significantly to 36 percent and during the lead extraction procedure the device was replaced as well.

• Brand Name: ITREVIA 5 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8292670
• MDR Text Key: 134591282
• Report Number: 1028232-2019-00300
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 402657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 04/01/2019; 04/01/2019
• Supplement Dates FDA Received: 04/30/2019; 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization