MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO SD 60/16; ICD LEAD

Model Number	399408
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Low impedance (2285)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Lead remains implanted.Representative reported an aborted shock during a vf episode due to shock impedance less than 20 ohms.Lead trends appeared stable.Full lead evaluation in office recommended.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.
Additional Manufacturer Narrative
Lead was explanted due to low impedance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.

• Brand Name: PROTEGO SD 60/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11642550
• Report Number: 1028232-2021-01708
• Device Sequence Number: 3156830
• Product Code: NVY
• UDI-Device Identifier: 04035479136093
• UDI-Public: 04035479136093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2021

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 Expiration Date: 05/31/2017
• Device Model Number: 399408
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/14/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/14/2021; 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR