MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problem Fracture (1260)

Patient Problems Laceration(s) (1946); Paralysis (1997); Seizures (2063)

Event Type  Injury  

Event Description

An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients.One patient presented vocal cord paralysis and underwent lead replacement.Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant.Two patients presented increased seizures and underwent vns replacement.Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead.The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis.The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia.The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia.The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement.The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement.The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein.The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• 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: 5116364
• MDR Text Key: 27203598
• Report Number: 1644487-2015-05985
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/06/2015

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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