MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART SD 65/18; ICD LEAD

Model Number 359067

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of about 72 months, it was reported that the icd could no longer be interrogated.During the revision op, it was noted that the lead was torn off the icd, which had happened in the section between shock coil and lead bifurcation.Icd and lead were explanted and returned to biotronik for analysis.

Manufacturer Narrative

The analysis of the lead fragment showed multiple strong signs of abrasion.In particular 22.5 cm to 23 cm distal of the is-1 connector pin, the insulation was damaged due to fraying.The inner conductor helix showed a helix fracture in this area.The distal end of the helix fracture and the rope conductor to the rv shock electrode showed traces of molten material.In addition, the coating of the rope conductors to the ring electrode and to the svc shock coil was damaged.This damage manifestation confirms the tear between svc shock electrode and fork mentioned in the complaint.The position and kind of the instances of fraying and the characteristics of the inner conductor helix fracture are indications of massive mechanical stress on the lead due to strong pressure onto the generator housing with simultaneous friction.There were no indications of material defects or manufacturing errors.

• Brand Name: LINOX SMART SD 65/18
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 5597552
• MDR Text Key: 43323215
• Report Number: 1028232-2016-01330
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 359067
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization