• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 07/12/2007
Event Type  Injury  
Event Description

On (b)(6) 2013, the patient¿s mother reported that the vns has caused him to lose the ability of his vagal nerve and also caused his stomach to stop working properly. The patient had to have a feeding port put in. The mother stated that the infrared actually ¿revved up¿ his vns.

 
Event Description

On (b)(6) 2013 when it was reported that the infrared on the wii almost burned out her son¿s vagal nerve and he has lost the ability to use his esophagus and had to have a feeding port put in. The reporter indicated that her son¿s problems began when they got a wii video game system about six years ago. She said that the infrared (ir) on the wii system revved up the vns to the point that it affected his voice and said you could see his neck pulsating. She said this happened every time her son was in the direct path of ir remote or receiver. She says that she did her own test using a board and a pillow - and she used this to block the ir signal. With the board and pillow blocking the ir signal, the patient was fine, but as soon as it was removed, the patient started exhibiting these adverse effects again (voice alteration and pulsating neck). She said that things started to get worse for her son, and in 2011, her son lost the ability to use his esophagus. She said she observed problems with choking and swallowing. She said she became very concerned about this when the patient started choking and aspirating and became unconscious. She says that an ambulance was called, and the patient was taken to the hospital. She said the physician at the hospital did an endoscopy and another test and found out that the patient lost motility of his esophagus and had problems with his stomach emptying. It was also said that the patient had ileus (bowel obstruction). The patient had to get a feeding port put in and during the implantation of the port, whatever they were giving him caused him to go into shock, and his heart stopped. She said the patient "came back" before they had to use the paddles to revive him. The reporter indicated that all these problems and complications boiled down to the vns device, so she had requested that the device be turned off. She said that she asked the physicians at the hospital to turn it off, which she thought they did, but it turns out they didn¿t. Their normal neurologist interrogated the device and saw it was still programmed on; therefore, the neurologist programmed the device off about 6 months ago. The reporter stated that after the device was disabled, the patient has been doing fine, and is even getting some motility in his esophagus back. Good faith attempts for further information from the neurologist have been unsuccessful. It was previously reported in (b)(6) 2011 that the patient was having problems with regurgitation and choking. The problem begins 3-4 hours after the patient is done eating and started a couple of months ago.

 
Event Description

On (b)(6) 2013 the patient¿s mother reported that since (b)(6) 2013, the patient has had to have his feeding port replaced at the hospital 5 times as he rips them out immediately after having them put in. The patient no longer has a feeding port and is now eating only soft foods and will be having a swallow test.

 
Event Description

It was reported that the patient's vns was programmed off on (b)(6) 2012. The physician reported that the patient's pulsating neck and voice alteration first occurred in 2006 and that the difficulty swallowing and choking, aspiration, and loss of consciousness began in (b)(6) 2011. It was reported that the patient went into shock and his heart stopped which was a reaction to tp nutrition and not related to vns therapy. It was reported that the loss of consciousness was unrelated to vns therapy and that the loss of motility of the patient's esophagus was unlikely related to vns therapy. The physician reported that the patient's pulsating neck, voice alteration, difficulty swallowing and choking, and aspiration are possibly related to vns therapy. The patient's mother reports that the patient's gi motility has returned to normal. The patient has no history of these events prior to vns therapy.

 
Event Description

The patient's mother reported that the patient was doing well. No adverse events were reported. The patient was in the hospital on (b)(6) 2013, but no other information was provided.

 
Manufacturer Narrative

 
Event Description

On (b)(6) 2013, the patient's mother reported that the patient had the feeding port removed and "everything" was working functionally. The mother indicated that the patient's device was turned off, the patient's symptoms started to go away, and the patient has improved. Additional attempts were made to the physician for information; however, they were unsuccessful. No additional information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key3127809
Report Number1644487-2013-01567
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102
Device LOT Number016030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/14/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/23/2013 Patient Sequence Number: 1
-
-