MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SETROX S 53; PACER LEAD

Model Number 350974

Device Problem Kinked (1339)

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

Event Date 12/30/2015

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of 114 months, it was reported that the ra lead was attempted to be repositioned during a revision op.In the process, a kink was noticed in the lead, and the stylet could not be pushed through for that reason.The pacing threshold could not be measured.The lead was explanted and returned to biotronik for analysis.No worsening of the patient's state of health was reported.

Manufacturer Narrative

On 4/19/16 - we were informed this event was originally reported with the wrong serial number of (b)(4) and model name and number of selox sr 53.These have been corrected.The implant date was removed, because we were not informed when this device was implanted.The returned lead fragments were thoroughly analyzed.During the analysis, multiple signs of abrasion were seen.In particular at 38 cm proximal of the tip electrode, the insulation was damaged by fraying.In this area, the inner conductor helix showed a conductor fracture.This damage manifestation can with high probability be considered the cause of the clinical complaint.The position and kind of the damage are characteristic for massive mechanical stress on the lead due to strong pressure onto the generator housing with simultaneous friction at it.Further examinations showed multiple deformations of the outer conductor helix, which were probably caused by an unfavorable position in relation to the generator housing.The distal part of the lead that was detached from the adhesive ring connection is with high probability a result of tensile forces during the explantation process.There were no indications of material defects or manufacturing errors.

• Brand Name: SETROX S 53
• Type of Device: PACER 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: 5431988
• MDR Text Key: 38063332
• Report Number: 1028232-2016-00351
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 350974
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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