MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 HF-T QP DF4 IS4 PROMRI; NO MATCH

Model Number 401657

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

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

Event Date 04/15/2023

Event Type  malfunction  

Event Description

At follow-up in feb., the device had 10 percent battery left.On april 14, an abnormality was detected during the mri scanning without program to mri mode, and the mri scan was stopped.In the next day, the device showed eos indication.Patient was transferred to the hospital.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned data.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.The final acceptance test proved the icd functions to be as specified.The returned follow-up data have been analyzed.The analysis confirmed the activation of the battery status eos on april 14th, 2023.No ram dump of the icd was available for analysis.Solely based on the follow-up data, no conclusion can be drawn regarding the activation of the eos battery status.However, it is reasonable to assume that the mri scan without previous activation of the mri mode, as mentioned in the complaint description, led to this observation.In general, 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 eos battery status.This behavior does not represent a battery or hybrid malfunction.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The clinical observation presumably resulted from the reported mri scan.

• Brand Name: IPERIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: NO MATCH
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16904184
• MDR Text Key: 314931246
• Report Number: 1028232-2023-02349
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 401657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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