MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Cardiac Arrest (1762); Necrosis (1971); Nerve Damage (1979); Seizures (2063); Therapeutic Response, Decreased (2271); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Follow up with the physician was performed.The physician stated that he had reported these events to the manufacturer in time and he was not willing to support any further dialog regarding these issues.The physician confirmed that there were no critical situations around the vns and that in cases where vns was critical, the device had been disabled and/or explanted.No additional information was provided.

Event Description

The abstract of the article ¿vagus nerve stimulation therapy in epilepsy patients.Long-term outcome and adverse effects: a retrospective analysis¿ was received and reviewed by the manufacturer.Please see abstract below: ¿background: vagus nerve stimulation (vns) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years.Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown.It is considered to be low in adverse effects.Topics: decision-making process on vns therapy as well as long-term outcome and adverse effects.Method: retrospective analysis of all 62 patients treated over a long period by vns in the epilepsy center of the university hospital of freiburg (germany) from (b)(6) 2002 through (b)(6) 2011.Results: outcome: the results show that 2 out of 62 patients became seizure-free under vns therapy while maintaining the already existing anti-ictal medication and 4 more patients under vns plus dosage increase of the already existing medication and/or new medication.However, in 34 out of 62 patients vns therapy did not improve the seizure situation.Adverse effects: vns is not as low in adverse effects as is generally considered.Only 9 out of 62 patients did not show any adverse effects and on the other hand severe, even life-threatening adverse effects also occurred.Conclusion: patients undergoing vns therapy have to be carefully checked for possible adverse effects, not only at the beginning of vns therapy but also in the long-term course.These results have to be considered in the cost-benefit analysis of this treatment.¿ the article, written in german, was later received by the manufacturer.Per the article, thirteen patients experienced adverse events related to the vns surgery or vns.A translation of the chart with patient information and outcomes revealed the following adverse events were observed: necrosis, increase in seizures (that were possibly psychogenic), wound infections, secondary rupture of sutures, recurrent laryngeal nerve paresis, horner¿s syndrome, wound dehiscence, lead break, and asystole.The following manufacturer report numbers are associated with each patient and their respective events: mfr #: 1644487-2014-00031 -- asystole, associated with vns.Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery.Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns.Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns.Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns.Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery.Mfr #: 1644487-2014-00037 -- lead break.Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery.Mfr #: 1644487-2014-00039 -- wound infection and secondary rupture of sutures associated with complications from surgery.Mfr #: 1644487-2014-00040 -- necrosis, associated with complications from surgery.Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery.Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery.Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.

Manufacturer Narrative

Date of birth, corrected data: initial mdr inadvertently provided the incorrect information.Sex, corrected data: initial mdr inadvertently stated this information was unknown; however, the information was known at the time.If implanted, corrected data: initial mdr inadvertently provided the incorrect information.Describe event or problem, corrected data: the initial mdr inadvertently referenced the related mfr numbers incorrectly.The following manufacturer report numbers are associated with each patient¿s respective events reported in the article: mfr #: 1644487-2014-00031 -- asystole related to vns.Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery and psychotic episodes associated with vns.Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns.Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns.Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns.Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery.Mfr #: 1644487-2014-00037 ¿ lead break.Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery.Mfr #: 1644487-2014-00039 -- necrosis, associated with complications from surgery.Mfr #: 1644487-2014-00040 -- wound infection and secondary rupture of sutures associated with complications from surgery.Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery.Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery.Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 3549167
• MDR Text Key: 4161409
• Report Number: 1644487-2014-00037
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• 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
• Date Manufacturer Received: 01/13/2014
• 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): Other