MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 HF-T QP DF4 IS4 PROMRI; ICD

Model Number	429561
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
It was reported that approx.15 days after the implantation there may be an inappropriate shock due to a crt-d failure.Furthermore, patient was diagnosed with hyperkalemia.The patient was hospitalized and pulse generator reprogramming was done.For diagnostic reasons chest x-ray and blood tests were done.Patient was treated with antibiotics and treatment with aldactone was stopped.Patient got a surgical intervention (securing screw connection of rv lead to crtd).
Additional Manufacturer Narrative
The icd and the lead were not returned for analysis.The analysis is therefore only based on the returned data as well as on the inspection of the quality documents associated with the manufacture of these particular devices.The manufacturing process for the icd and the lead were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test of the icd proved the device functions to be as specified.The returned follow-up reports have been analyzed.No shock delivery was recorded in the available data.The last charging cycle was started on (b)(6) 2020, during episode no.154 after a vf was detected.The episode was terminated spontaneously, and no shock was delivered.However, no iegm is available in the follow-up data for this episode.The rv-pacing impedance data was analyzed and showed an increasing trend after (b)(6) 2020.The root cause for this trend was not determinable based on the available data.Based on the information available for analysis no conclusion can be drawn regarding the root cause of the clinical observation.However, should additional relevant information become available this investigation will be updated.

• Brand Name: RIVACOR 5 HF-T QP DF4 IS4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 10693184
• Report Number: 1028232-2020-04482
• Device Sequence Number: 10905550
• Product Code: NIK
• UDI-Device Identifier: 04035479156879
• UDI-Public: 04035479156879
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 429561
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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