MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 HF-T QP DF4 IS4 PROMRI

Model Number 401657

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.81 months, it was reported that the device shows the eos status.The icd was explanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the battery status eos, 32 charging cycles were recorded to the device memory.The memory content of the device was inspected.During the inspection of the available iegms noise was observed in the right ventricular and far-field channel of episode 28, recorded on april 04, 2022.The data further showed, that the device automatically activated the battery status eos on the same day at 13:27 pm.The frequency and morphology of the sensed signals of episode 28 can be most probably attributed to strong external electromagnetic fields as used by magnetic resonance imaging.The mri mode was not activated on april 04.The eos state was removed with a technical programmer and subsequent interrogation showed the device status mos2.The battery voltage of 2.84 v revealed a charged battery.Following, 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 and the charging time was as expected.In addition, the manufacturing process for this device 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 device functions to be as specified.Based on the analysis results, the eos status most likely resulted from a mri scan without prior activation of the mri mode.If a charging cycle occurs in a strong external magnetic field, depending on strength and orientation, a saturation of the high voltage transformer may appear, leading to a temporary drop of the supply voltage below the eos level, resulting in the observed battery status eos.This observation does not represent a battery or hybrid malfunction.The analysis did not reveal any indication of a device malfunction.

• Brand Name: IPERIA 7 HF-T QP DF4 IS4 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14079365
• MDR Text Key: 289081958
• Report Number: 1028232-2022-01850
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 401657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• 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