MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 DR-T DF4 PROMRI; ICD

Model Number 429524

Device Problem Ambient Noise Problem (2877)

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

Event Date 04/12/2021

Event Type  malfunction  

Event Description

It was reported that noise was detected on this patients rv lead.Physicians were unable to determine if the noise was due to the lead or the device.The device was explanted on (b)(6) 2021 and the lead was capped.

Manufacturer Narrative

The lead under complaint was not returned for analysis.This report is therefore only based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacture of the lead and the icd.The manufacturing processes for the lead and the icd were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Upon receipt, the icd was interrogated, revealing the battery status eos.The icd was implanted for about 6 months and 2 charging cycles were recorded to the icds memory.The header of the icd was inspected and showed no anomalies.The memory content of the device was inspected.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 applied heart signals free of noise, proving the sensing function of the icd to be normal and as expected.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.In conclusion, the lead was not returned for analysis.The memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms no noise has been detected.However, a thorough analysis of the icd proved the device to be fully functional.The integrity of the lead cannot be assured.There was no indication of a material or manufacturing problem.

• Brand Name: ACTICOR 7 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11790381
• MDR Text Key: 249463759
• Report Number: 1028232-2021-02366
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 04035479156695
• UDI-Public: 04035479156695
• 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
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 429524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization