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

Model Number 393030

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

Device is at eri indication with unexpected battery behavior.No adverse patient events were reported.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was explanted on (b)(6) 2023.

Manufacturer Narrative

The device was explanted on (b)(6) 2023.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.As a first step in the analysis, the device was interrogated.The interrogation could be properly performed, and it revealed the battery status eri.Further analysis of the icd memory content showed a normal current consumption.However, the amount of charge taken from the battery was verified and the battery condition was not as expected.In order to obtain further insights, the icd was opened, and the inner assembly was inspected.The visual inspection showed no anomalies.The overall current consumption of the electronic module was verified by direct measurement and proved to be normal and as expected.There was no indication of a malfunction of the electronic module.Battery voltage measurement confirmed a depleted battery that can be attributed to an increased internal self-depletion within the battery as a result of lithium plating.This icd is part of the population affected by the field safety notification regarding potential premature battery depletion due to lithium plating from march 2021.

• Brand Name: IPERIA 7 VR-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: 16807111
• MDR Text Key: 313932425
• Report Number: 1028232-2023-02051
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 393030
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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