MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem Fall (1848)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

It was reported that device diagnostics resulted in high impedance (>10,000 ohms) on (b)(6) 2014 and again on (b)(6) 2014.It was reported that x-rays did not show an obvious lead break.It was reported that device diagnostics during generator replacement in (b)(6) 2013 were within normal limits (2640 ohms).There was no trauma or patient manipulation that is believed to have caused or contributed to the high impedance.X-rays were sent to manufacturer for review.Review of x-rays identified that the lead pin did not appear to be fully inserted into the generator header.Clinic notes dated (b)(6) 2014 note that device diagnostics showed impedance value - >10,000 ohms.It was noted that the patient suffered a bad fall approximately one months prior and that the patient has a tendency of striking his fists against his upper chest.The patient also uses his fingers to tug on his clavicles.It was noted that any of these activities may have dislodged the lead pin or produced a fracture in the lead.The patient was referred for surgery.During surgery, the lead pin was removed and then reinserted into the generator header.Device diagnostics were then within normal limits.The high impedance is related to the lead pin not being fully inserted into the generator header.

Manufacturer Narrative

Adverse event or product problem, corrected data: previously submitted mdr indicated that the event was only a product problem; however, this should have also been reported as an adverse event.This report is being submitted to correct this information.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3793934
• MDR Text Key: 4372118
• Report Number: 1644487-2014-01210
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2014
• Device Model Number: 105
• Device Lot Number: 202224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• 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 Age: 17 YR