MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO TD 65/16; ICD LEAD

Model Number	359076
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was capped due to high thresholds.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: PROTEGO TD 65/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7619800
• Report Number: 1028232-2018-02092
• Device Sequence Number: 1623854
• Product Code: NVY
• UDI-Device Identifier: 04035479100490
• UDI-Public: (01)04035479100490
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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 Model Number: 359076
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/12/2018
• 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: 47 YR