MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 5 DR-T DF4 PROMRI; ICD

Model Number 404687

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

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

Event Date 09/14/2021

Event Type  Injury  

Event Description

On (b)(6) 2018, the icd was implant with a ra and rv coil lead.On (b)(6) 2021 received a first noise alert on the rv coil lead on a home monitoring website.On (b)(6) the patient had a series of 49 shocks due to noise on rv channel.The lead and the icd were explanted and replaced.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.

Manufacturer Narrative

The icd and the lead under complaint were returned and subjected to an extensive analysis.The icd was interrogated, revealing the battery status mos1.The amount of charge taken from the battery was verified and the battery condition was normal and as expected.The inspection of the icd memory content confirmed the clinical observation.However, there was no indication of an icd malfunction.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis showed multiple abrasion marks along the lead.In particular 57.5 cm distal to the df4 connector pin the insulation was found rubbed through, which is assumed to be the root cause of the reported oversensing leading to inappropriate shocks.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.Further damages such as a fractured conductor cable leading to the ring electrode and a deformed rv shock coil, most likely resulted from the extraction procedure due to tensile stress.The manufacturing processes for these devices were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.The icd showed no anomalies.The battery condition was as expected.

• Brand Name: INTICA 5 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12519217
• MDR Text Key: 272904992
• Report Number: 1028232-2021-05227
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 404687
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization