MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SAFIO S 53; PACING LEAD

Model Number	370945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lead showed an insulation damage during the extraction of the associated icd lead.
Additional Manufacturer Narrative
Upon receipt, the two leads under complaint were subjected to an extensive analysis.The performance of the devices was scrutinized, including a visual, electrical and mechanical inspection.The visual inspection of the plexa lead revealed abrasion marks along the lead body.Further inspection showed a squeezed and deformed lead body approximately 40cm distal to the df4 connector pin.In this region, the insulation and the coating of the conductor cables to the shock coil and the ring electrode were damaged.The conductor coil to the svc shock coil was fractured.These findings can be considered as the root cause of the reported oversensing with shock delivery.Based on the characteristics as well as the location of the damage, it is reasonable to assume that the lead had been subject to excessive mechanical forces as the result of clavicular first rib entrapment as mentioned in the complaint description.Furthermore, a kinked fixation helix, deformations of the shock coils, damages at the steroid collar and cuts int the insulation were found which occurred most likely during the explantation procedure.The analysis of the safio lead showed abrasion marks along the lead body and demonstrated a squeezed and deformed lead body approximately 33cm distal to the is-1 connector pin.Based on the characteristics as well as the location of the damage, it is reasonable to assume that the lead had been subject to excessive mechanical forces as the result of clavicular first rib entrapment.Further inspection of the safio showed a rubbed through insulation approximately 20cm distal to the is-1 connector pin, which most likely resulted from interaction with another implantable device such as the generator or the nearby lead.In addition, a deformed and elongated fixation helix was observed which occurred most likely during the explantation procedure.The manufacturing process for these two leads 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 of both leads did not reveal any sign of a material or manufacturing problem.

• Brand Name: SAFIO S 53
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9141719
• Report Number: 1028232-2019-04283
• Device Sequence Number: 16924867
• Product Code: NVN
• UDI-Device Identifier: 04035479113940
• UDI-Public: 04035479113940
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 03/31/2019
• Device Model Number: 370945
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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