MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SMART S 60; ICD LEAD

Model Number 375012

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

The patient's associated icd tripped inappropriate eri multiple times between (b)(6) and (b)(6) for an unknown reason.On (b)(6) 2016 the local sales representative called to report this patient presented to the er over the weekend where it was discovered this lead was fractured.This lead and the icd were explanted and replaced.

Manufacturer Narrative

Upon receipt, the lead was found cut approximately 11.5 cm distal to the is-1 connector pin.A proximal and a distal lead fragment were received and subjected to an extensive analysis.The inspection of the returned lead fragments revealed a damaged insulation approximately 38 cm proximal to the lead tip.In that section, the lead body was found squeezed and deformed.The inner conductor coil was found fractured as mentioned in the complaint description.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 of the available fragments did not reveal any sign of a material or manufacturing problem.Biotronik will monitor closely if complaints received in future point towards a common root cause.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.

• Brand Name: LINOX SMART S 60
• 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: 5866862
• MDR Text Key: 51875136
• Report Number: 1028232-2016-02871
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 375012
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2012
• 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
• Patient Age: 62 YR