MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 7 DR-T DF-1; ICD

Model Number	390064
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent an mr scan without being programmed to an mri mode.The device subsequently went eos.Per hm, the battery voltage was 3.08 v on (b)(6) 2019.Device was explanted and replaced.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
Additional Manufacturer Narrative
Upon receipt, the device interrogation revealed the eos battery status, 23 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the inspection of the available iegms noise was observed in the atrial, ventricular and far-field channel of episode 21, recorded on (b)(6) 2019.The data further showed, that the device automatically activated the eos battery status on the same day at 4:25am.The frequency and morphology of the sensed signals of episode 21 can be most probably attributed to strong external electromagnetic fields as used by magnetic resonance imaging.As reported, the mri mode was not activated on november 9.In a next step, the eos state was removed with a technical programmer and subsequent interrogation showed the device status mos1.The battery voltage of 3.08v 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 normal and expected 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 and all production steps were 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 an 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 eos battery status.This observation does not represent a battery or hybrid malfunction.The analysis did not reveal any indication of a device malfunction.

• Brand Name: IFORIA 7 DR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9322124
• Report Number: 1028232-2019-05018
• Device Sequence Number: 10867294
• Product Code: MRM
• UDI-Device Identifier: 04035479126926
• UDI-Public: 04035479126926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 390064
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 04/05/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/18/2019; 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 54 YR