MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939); Human-Device Interface Problem (2949)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Pain (1994); Seizures (2063); Choking (2464); Shock from Patient Lead(s) (3162)

Event Date 12/27/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, this patient reported that something was not right with her device.The patient went to the emergency room on (b)(6) 2014.The patient had bad bruising, and x-rays were taken which reportedly showed no wire (lead) issue.The device was not going off every five minutes as it was supposed to.The device was reportedly randomly giving ¿double doses¿ (magnet mode stimulation) and was causing pain.On (b)(6) 2013, an er physician reported that the patient was complaining of shocking at the battery site.On (b)(6) 2013, the patient reported an increase in seizures since being implanted in (b)(6) 2013.Per the patient¿s stepfather, the device was malfunctioning, constantly shocking, and could not be turned off.Clinic notes dated (b)(6) 2014 indicated that the patient had a vns placed on (b)(6) 2013 and had no benefit from it.[clinic notes dated (b)(6) 2013 (prior to vns implant) indicate the patient had six seizures in the last two months.] the device began to be dysfunctional on (b)(6) 2013.The patient felt like she had a tens unit in her chest.She felt the shocking at the generator site, not the electrode site.The patient felt like the generator had fallen down and to the left.The patient¿s mother felt a buzzing when she touched the patient¿s chest.The patient was seen in the er for this and a bloody nose.Per the patient¿s mother, the patient was having double seizures: a gtc seizure followed by another one a few minutes later.This happened three times since the device began to malfunction.At a previous visit, the device was programmed off, but the symptoms persisted.Give the patient¿s history of psychiatric overlay, it was unclear if this was an actual dysfunction of the device or another manifestation of psychiatric diagnostic.On (b)(6) 2013, it was reported that the patient¿s device was disabled on (b)(6) 2014 due to the shocking sensations; however, it was also reported that it was disabled due to random activations reported in manufacturer report number: 1644487-2013-03481.On (b)(6) 2013, it was reported that the generator had migrated.It was also reported that this vns patient was beaten by her ex-boyfriend.Since that time, the generator has migrated, and she has been feeling ¿shocking¿ sensations with stimulation.Per the patient, the physician could not disable the device; however, it was confirmed the device was disabled.On (b)(6) 2014, it was reported that the patient¿s device was disabled but was still shocking her.The patient was only titrated up one time since implant, which is likely the reason for lack of efficacy.The patient was referred for an eeg.There was no high lead impedance.Clinic notes dated (b)(6) 2014 were received which indicate that around christmas, the patient was beaten up by her boyfriend at the time.Per the notes, the patient was beat so severely that she has had trouble with the vns since.The patient says the generator will shock her at times and there has been difficulty turning the device off.The notes state the incisions appear to be well healed and there is no evidence of infection.The generator does not appear to be off and does not appear to have any gross malfunction to it.However, when the patient swipes the magnet she experiences coughing as well as a change in her voice.The generator was interrogated again and seen to be turned off, so the physician states that it is unclear what is happening, but the patient is experiencing symptoms.The physician states that they will keep the device off for now, and consider replacing the generator.Surgery is likely, but has not occurred to date.

Event Description

The patient reported that she can see the lead protruding under her skin when she bends over.It was reported that the patient underwent generator replacement on (b)(6) 2014.Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

• Brand Name: PULSE GEN MODEL 103
• 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: 3597907
• MDR Text Key: 4092187
• Report Number: 1644487-2014-00314
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/05/2014

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
• Device Expiration Date: 04/30/2015
• Device Model Number: 103
• Device Lot Number: 202485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 01/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• 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
• Patient Age: 17 YR