MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 HF-T PROMRI DF4; CRT-D

Model Number 390113

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

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2016

Event Type  malfunction  

Event Description

Ous mdr - the patient with this device went for an mri, but the mri setting on the device was not set and now it shows eos.The mri was on the brain.Currently this device remains implanted awaiting recommendations on how to further proceed.

Manufacturer Narrative

The patient was hospitalized and the physician decided to try the device reset procedure.The device recovered from the eos mode, and both impedance and thresholds in the right and left chambers were fine.A manual capacitor reformation was performed as well.After reset, the device measured a battery life of 89 percent.At some point after (b)(6) 2016, this device was explanted and returned for analysis.The date of explant is unknown.The device was received and analyzed.Prior to the analysis of the device, the available ram dump data were inspected.The inspection confirmed that the device activated the eos status on 29-oct-2016.The available iegms from 29-oct-2016 (episode 145) showed external interfering signals in the rv and farfield channel.The frequency and morphology of the sensed interfering signals as well as the eos detection can be attributed to strong external electromagnetic fields, likely due to the reported mri scan.The inspection of the memory content of the icd showed that the device was reset on 31-oct-2016, as mentioned in the complaint description.Afterwards the battery status was mos1.At a next step the device was subjected to an electrical analysis.The device interrogation confirmed the battery status mos1.An amount of 10 charging cycles was documented.A sensing test was performed and the device sensed the attached heart signals free of noise.The icd was subjected to an electrical analysis.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 device proved to be fully functional.The observed device behavior was most probably caused by a strong external magmatic field during the magnetic resonance imaging.As reported, the mri mode of the icd was not activated at that time.There was no indication of a material or manufacturing problem.

• Brand Name: IFORIA 5 HF-T PROMRI DF4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6118959
• MDR Text Key: 60621090
• Report Number: 1028232-2016-04636
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 390113
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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; Other