MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SOLIA T 60; PACING LEAD

Model Number	377181
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pacing impedance was too high and out of range and the pacing thresholds increased.The lead was explanted and replaced approx.38 months after the implantation.Please note that the incident was already reported by the health facility.The serial number in that report was mistaken.Solia t 60, sn 8000428942 was implanted during the procedure.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was found cut 50 cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment was not returned.An extraction aid was found on the fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the lead tip was found covered in fibrotic growth.Calcifications are known to cause high impedances and pacing thresholds and is thus assumed to be the root cause of the clinical observations.Furthermore, cuts into the insulation were found 34 cm proximal to the lead tip, which most likely resulted from the extraction procedure.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SOLIA T 60
• Common Device Name: PACING 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: 15127346
• Report Number: 1028232-2022-03826
• Device Sequence Number: 6625547
• Product Code: NVN
• UDI-Device Identifier: 04035479118297
• UDI-Public: 04035479118297
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 02/28/2021
• Device Model Number: 377181
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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