MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 HF-T DF4 PROMRI; CRT-D

Model Number 393009

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

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

Event Date 12/18/2020

Event Type  malfunction  

Event Description

It was reported after approx.54 months implantation time, that eos (end of service) was detected.

Manufacturer Narrative

Device was explanted on (b)(6) 2020 and returned for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.Therefore, the device was opened, and the inner assembly was inspected.The measurement of the battery voltage showed a depleted battery.The visual inspection of the electronic module revealed deposits on parts of the electrical components and discoloration of various low voltage capacitors.The origin of these deposits could not be conclusively determined during analysis.The electronic module was attached to an external power supply to test the functionality of the module.Thereby, an elevated current consumption was measured.Further thorough investigation showed that the observed deposits on several electrical components created low resistance paths increasing the current consumption of the electronic module.The ability of the electronic module to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.The shock therapy capability of the icd could not be tested due to the above mentioned deposits on the electronic module.In conclusion, the clinical observation resulted from an early battery depletion caused by an elevated current consumption of the electronic module.The elevated current consumption occurred due to deposits on several electrical components.The origin of these deposits could not be conclusively determined during analysis.

• Brand Name: IPERIA 7 HF-T DF4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11152403
• MDR Text Key: 226237147
• Report Number: 1028232-2021-00139
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479129255
• UDI-Public: 04035479129255
• 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
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 393009
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization