MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX ST 60; PACER LEAD

Model Number 346367

Device Problem Kinked (1339)

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

Event Type  malfunction  

Event Description

Ous mdr.It was reported that this "kinked lead and wire came out with the cover lead".There were no event or explant dates provided, but this lead was returned for analysis.If additional information becomes available, this event will be updated.

Manufacturer Narrative

The analysis of the lead demonstrated a damaged insulation and a fractured outer coil at a distance of some 27 cm distal to the is-1 connector pin.In that section, the lead body was found squeezed and deformed.The outer coil was found fractured.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.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SELOX ST 60
• Type of Device: PACER LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 3635387
• MDR Text Key: 3984200
• Report Number: 1028232-2014-00468
• 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
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 346367
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2012
• 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