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

Model Number	393009
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device was explanted and replaced due to high impedance that was seen on lead that may be result of an issue with the df4 port and set screw area with this device.Should additional information be obtained, this report will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status mos1.The icd was implanted for 49 months and 18 charging cycles were recorded to the device memory.The header of the icd was visually inspected, revealing no anomalies.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.All dimensions of the header bores were within the range requested by the is-1 and df4 standard specifications.Also the spring elements of the device did not show any deviations.In a next step, 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 normal and expected sensing and shock delivery.In particular, the specified energy level was reached.Furthermore, a sensing test was performed and the device sensed the attached heart signals free of noise.The impedance measurement functions of the icd were tested and the icd proved to work as expected.The clinical observation was not reproducible.In conclusion, the device proved to be fully functional.There was no indication of a device malfunction.

• 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: 10670544
• Report Number: 1028232-2020-04401
• Device Sequence Number: 2508705
• Product Code: NIK
• UDI-Device Identifier: 04035479129255
• UDI-Public: 04035479129255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 10/31/2017
• Device Model Number: 393009
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 09/05/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 09/13/2021
• 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
• Patient Age: 66 YR