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

Model Number	393009
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after approx.54 months implantation time, that eos (end of service) was detected.
Additional 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
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11152403
• Report Number: 1028232-2021-00139
• Device Sequence Number: 16310259
• Product Code: NIK
• UDI-Device Identifier: 04035479129255
• UDI-Public: 04035479129255
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2020

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: 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
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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