MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX JT 45; PACING LEAD

Model Number	346369
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead capped due to twiddlers syndrome.This lead was originally pulled out by the patient leading to non-capture.Due to the occlusion of the veins on the left side however, the physician chose to cap the lead and abandon the system on the left side in favor of a competitor system on the right side.Should additional information become available, it will be added to this file.
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.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: SELOX JT 45
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12339438
• Report Number: 1028232-2021-04642
• Device Sequence Number: 14154711
• Product Code: NVN
• UDI-Device Identifier: 04035479077877
• UDI-Public: 04035479077877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Model Number: 346369
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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
• Patient Age: 76 YR