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

Model Number	379967
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.29 months after the implantation this lead was explanted due to suspicion of a lead damage.The lead impedance measurement were out of range (greater than 3000 ohms).
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 13 cm distal to the df4 connector pin.Both fragments were received for analysis.Explantation aids were still inserted in and mounted on the distal lead fragment.It is reasonable to assume that the lead was cut during the extraction procedure.The returned lead fragments were visually and electrically analyzed.The visual inspection revealed that the insulation was, apart from the present fragmentation and extraction damages, free of breaches.During the electrical analysis, the dc resistances of the received conductor fragments were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.Additional damages like the cuts into the insulation 14 and 34 cm distal to the df4 connector pin most likely occurred during the extraction procedure.Damages like the deformed rv shock coil, the from the insulation ruptured passive fixation and the into the insulation retracted lead tip most likely occurred during the extraction procedure due to tensile stress.The passive fixation was not returned.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: PROTEGO T 65
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10264018
• Report Number: 1028232-2020-02826
• Device Sequence Number: 16905236
• Product Code: NVY
• UDI-Device Identifier: 04035479121686
• UDI-Public: 04035479121686
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 08/31/2019
• Device Model Number: 379967
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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