MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Seizures (2063); Tingling (2171)

Event Date 09/20/2016

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2016 that the patient¿s device was interrogated by the physician and high lead impedance was discovered.A diagnostic test was done and confirmed the high lead impedance.The device was being turned off and patient was being sent for x-rays.It was stated that the patient has seizures where he falls and possibly could have landed on his chest.Patient does say he has intermittent tingling in the chest pocket area.The patient¿s last interrogation in (b)(6) 2016 did not show high impedance.Two anterior/posterior and 2 lateral chest and neck x-rays for the patient were reviewed on (b)(6) 2016.The x-rays were provided for a high impedance event identified on (b)(6) 2016.The x-rays showed that the lead pin is not fully inserted into the connector block, as the connector pin cannot be visualized past the connector block.The generator was placed in the left chest per labeling, and the feedthru wires appeared intact at the connector block.No gross fractures were identified with the provided images.No sharp angles were noted.Additionally, a portion of the lead was identified to pass behind the generator and an assessment could not be made on this portion of the lead.No gross discontinuities were identified, but a micro-fracture and a lead discontinuity with the portion of the lead behind the generator cannot be ruled out.The cause of the alleged high impedance may be due to the incomplete pin insertion or a micro fracture.Although surgery is likely, it has not occurred to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6023750
• MDR Text Key: 57317200
• Report Number: 1644487-2016-02340
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2004
• Device Model Number: 302-20
• Device Lot Number: 6312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2002
• 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): Required Intervention
• Patient Age: 43 YR