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 02/11/2023

Event Type  malfunction  

Event Description

After an implantation period of approx.77 months, it was observed via homemonitoring that the device shows the eos status.The patient was hospitalized.Device remains implanted at this time.Should additional information be received, this file will be updated.

Manufacturer Narrative

It was reported that the patient underwent an mri on (b)(6) 2023 without notifying staff about his implant.The eos alert was received the day after this mri.The device was explanted on (b)(6) 2023.

Manufacturer Narrative

It was reported that the patient underwent an mri on (b)(6)2023 without notifying staff about his implant.The eos alert was received the day after this mri.The device was explanted on (b)(6)2023.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 reviewed.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 data have been analyzed.The analysis confirmed the activation of the battery status eos on the same day the patient received an mri scan.Not enough data were available for a root cause investigation.However, based on the available information, it is reasonable to assume that the reported mri might have led to the eos activation.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.Without relevant data or an analysis of the icd the root cause of the clinical observation is not determinable.

• 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: 16403347
• MDR Text Key: 309860732
• Report Number: 1028232-2023-00897
• 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,Followup
• Report Date: 10/26/2023

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: 08/31/2017
• Device Model Number: 401657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 03/03/2023; 10/26/2023
• Supplement Dates FDA Received: 03/06/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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