MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SIELLO JT 53; LEAD

Model Number	362704
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 97 months after implantation right ventricular oversensing was observed during an in- office follow up.The complete icd system including this atrial lead was removed.
Additional Manufacturer Narrative
Upon receipt, the fragmented lead was subjected to an extensive analysis.Multiple signs of abrasion were noted along the lead body.Further damages such as cuts in the insulation from an electrical scalpel were found and the lead tip was found torn apart.It is reasonable to assume that these damages resulted from the extraction procedure.With regard to the issues mentioned in the complaint description, the analysis did not show any deviations from the technical specifications.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.The analysis did not reveal any sign of a material or manufacturing problem.
Additional Manufacturer Narrative
Upon receipt, the fragmented linox smart sd 65/18 and siello jt 53 leads under complaint were subjected to an extensive analysis.Linox smart sd 65/18: the analysis showed multiple abrasion marks along the lead fragment.In particular in the distal area the insulation was found rubbed through which is assumed to be the root cause of the reported oversensing.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.Furthermore, the shock coils were found deformed, which most likely occurred during the extraction procedure.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.Siello jt 53: multiple signs of abrasion were noted along the lead body.Further damages such as cuts in the insulation from an electrical scalpel were found and the lead tip was found torn apart.It is reasonable to assume that these damages resulted from the extraction procedure.With regard to the issues mentioned in the complaint description, the analysis did not show any deviations from the technical specifications.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.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SIELLO JT 53
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 9299808
• Report Number: 1028232-2019-04950
• Device Sequence Number: 19365981
• Product Code: NVN
• UDI-Device Identifier: 04035479106249
• UDI-Public: 04035479106249
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: 02/28/2013
• Device Model Number: 362704
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 03/05/2020; 06/12/2024
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 03/05/2020; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown