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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); Twiddlers Syndrome (4563)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lead 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 the subject lead was removed due to inappropriate shocks.Accordingly, these shocks were a result of lead dislodgement caused by twiddlers syndrome.No patient files are available in relation to the reported issue.No known impact or consequence to the patient.

• 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: 10576807
• Report Number: 1028232-2020-04052
• Device Sequence Number: 17021026
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 07/31/2019
• 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: 09/23/2020
• Initial Report FDA Received Date: 09/23/2020
• 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