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

Model Number	399408
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Lead capped due to rv lead fracture.No adverse patient events reported.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.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 48 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment including the yoke and connector pins was not returned.An extraction aid was found on the lead body, it is reasonable to assume that the lead was cut during the extraction procedure.The performance of the lead fragment was scrutinized.The analysis showed multiple abrasion marks along the lead fragment.In particular the insulation in the distal end region was found damaged due to wear, which is assumed to be the root cause of the clinical observation.Based on the characteristics of this damage, it is reasonable to assume that the lead had been subject to severe mechanical stress in the implanted state.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should be taken into consideration.Further damages such as a deformed rv shock coil, most likely resulted from the extraction procedure due to tensile stress.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 SD 60/16
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11925360
• Report Number: 1028232-2021-03071
• Device Sequence Number: 3202452
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2021

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: 06/30/2016
• Device Model Number: 399408
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 08/19/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/14/2021; 08/23/2021
• 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: 66 YR