MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 5 HF-T DF-1 IS-1 PROMRI

Model Number	429567
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 17 months, it was reported that the whole system was explanted due to high shock impedance.
Additional Manufacturer Narrative
Intica neo 5 hf-t df-1 is-1 promri sn (b)(6) upon receipt, the icd was interrogated, revealing the bos battery status, four charging cycles were recorded to the devices memory.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 and the shock impedance was as expected.The impedance measurement functions of the device were tested and proved to be normal.In conclusion, the device was fully functional.There was no indication of device malfunction.Linox smart promri s 65 sn (b)(6) upon receipt the lead was found cut 14 cm distal to the is-1 connector pin into two segments.A proximal and a distal lead fragment were received for analysis.The analysis showed 1.5 cm distal to the df-1 connector pin that the conductor cable leading to the rv shock coil was found fractured, which is assumed to be the root cause of the reported high shock impedance.Based on the characteristics, as well as the location of the fracture, it is reasonable to assume that it was caused due to excessive mechanical forces in the implanted state against the generator housing in combination with tensile forces applied during the repositioning procedure.Further analysis revealed that the insulation was found rubbed through 7 cm proximal to the lead tip.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.Damages such as cuts into the insulation and a deformed rv shock coil, most likely resulted from the extraction procedure.Solia s 53 sn 25731565 upon receipt the lead was found cut 9 cm distal to the is-1 connector pin into two segments.A proximal and a distal lead fragment were received for analysis.The analysis revealed a ruptured insulation directly next to the ring electrode, a deformed fixation helix and cuts into the insulation which most likely resulted from the extraction procedure.Corox promri otw-l 85-bp sn (b)(6) upon receipt the lead was found cut 21 cm distal to the is-1 connector pin into two segments.A proximal and a distal lead fragment were received for analysis.An extraction aid was found on the distal lead body.The analysis showed further cuts into the insulation, which most likely resulted from the extraction procedure.The manufacturing processes for the devices under complaint were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: INTICA NEO 5 HF-T DF-1 IS-1 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12295177
• Report Number: 1028232-2021-04439
• Device Sequence Number: 1245367
• Product Code: NIK
• UDI-Device Identifier: 04035479156930
• UDI-Public: 04035479156930
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2021
• Device Model Number: 429567
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown