MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG VOLTA 1CR 65 US; ICD LEAD

Model Number	384075
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Liva nova/microport provided the following information: inappropriate shocks were reported on this lead.The interrogation revealed an rv coil impedance of 200 ohms beginning in (b)(6) 2020.Device therapy was turned off.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The analysis of the provided trend data, recorded between december 8th, 2019 and june 30th, 2020, showed the rv pacing impedance fluctuating between 200 and 600 ohms.An impedance test performed on june 6th, 2020, recorded the rv pacing impedance at less than 200 ohms, as indicated in the complaint.The analysis of the provided iegm episodes noted artefacts in the rv channel, which led to the reported oversensing and inappropriate shocks.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: VOLTA 1CR 65 US
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10251656
• Report Number: 1028232-2020-02797
• Device Sequence Number: 2425755
• Product Code: NVY
• UDI-Device Identifier: 04035479143374
• UDI-Public: 04035479143374
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 02/28/2018
• Device Model Number: 384075
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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