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

Model Number	384075
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment and no further information is expected.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
Oversensing and loss of capture was reported approx.62 months after the implantation.

• Brand Name: VOLTA 1CR 65 US
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 12160428
• Report Number: 1028232-2021-03942
• Device Sequence Number: 3713675
• Product Code: NVY
• UDI-Device Identifier: 04035479143374
• UDI-Public: 04035479143374
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 02/28/2017
• Device Model Number: 384075
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1