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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Device Problem Migration or Expulsion of Device
Event Date 11/01/2013
Event Type  Injury  
Event Description

It was later reported that the patient has ¿burn marks¿ over her lead. Good faith attempts for further information from the physician have been unsuccessful.

 
Event Description

On (b)(6) 2015 the patient reported that he is having serious problems with the vns. The patient later reported that she is still having neck pain and swelling in the left side of the neck, feeling vibration and pulsing. She also stated that when she places the magnet over the device, she feels that stimulation is stronger. She also coughed up some blood.

 
Event Description

A provider reported that the patient called her to schedule an appointment to check on her vns which since (b)(6) (2015) is causing burn marks. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the patient¿s left side of the neck is swollen from behind her left ear to down her neck, and that when she leans on her left side, she feels the battery sliding down underneath her axilla. It was reported that this has been going on for a year on and off and the welling would come and go. The patient reported that it started just prior to her cabg last year, but has worsened since that surgery. She said for the last week, it has remained swollen and she is coughing a bit of blood from her throat. The patient now wants the device removed. The patient saw a cardiologist and she doesn¿t have jvd, but the cardiologist stated that possible the lead was eroding the vocal cord area. The patient stated that she has had an mi and cva this past (b)(6) 2014. Per the patient¿s primary care physician, she does not need to see an ear, nose, and throat physician. However, the patient is still having neck swelling on the left side of her neck. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

 
Event Description

The patient indicated that she feels her lead has moved, is wrapped around her esophagus, is choking her and causing throat pain. She stated that she has continuous voice alteration but no longer feels device stimulation since the time of her last interrogation 2 months prior. She stated she has coughs up blood and has a tight feeling in her chest. She stated that her generator is under her armpit. She indicated her neurologist will be speaking with her other providers, including her cardiologist, for clearance to replace her generator and lead. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

 
Event Description

Information was received from two of the patient's physicians. The first physician indicated the last device check was on (b)(6) 2015 showing normal battery status, normal lead impedance and no vns parameters were altered. The physician indicated that the patient has not reported any of the prior symptoms to him. The second physician indicated the last device check was (b)(6) 2015 and the device battery was indicated to be at end of service, lead impedance was ok and no parameters were changed. He indicated that that patient had reported dysphagia and throat pain but none of the other prior symptoms. No specific interventions were undertaken. Clinic notes were subsequently received for the (b)(6) 2015 office visit which indicated that the device would be replaced due to end of service. The notes indicated that the vns give her trouble with breathing but no specific intervention is referenced. The patient subsequently called the manufacturer and reported that her seizures were worse than before vns. The patient underwent pulse generator replacement on (b)(6) 2015 however high lead impedance was detected when the indwelling lead was connected with the new pulse generator despite repeated removals and insertions. The surgeon elected not to replace the lead during the surgery. Post-implant lead impedance also measured high. Lead impedance with the prior pulse generator was normal. Review of prior programming and diagnostic data reveals fluctuating lead impedance suggesting an intermittent short circuit condition. A battery life calculation using the available programming history showed approximately 0. 2 remaining until neos = yes. No known additional surgical interventions have occurred to date.

 
Event Description

Information was received indicating that the patient was scheduled for lead revision surgery. The patient subsequently reported that she was hospitalized due to multiple seizures and stated she was experiencing unusual seizures. The patient underwent surgery for the high impedance condition as reported and described in mfr. Report # 1644487-2016-00375.

 
Event Description

Operative notes containing a record of the pulse generator replacement on (b)(6) 2015, during which high impedance was observed following connection of the new generator to the indwelling lead, were received. The operative notes state that it was suspected that the high impedance measurement may possibly be due to emi from surrounding medical devices and was therefore left in place for interrogation in the postanesthesia care unit.

 
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Brand NameLEAD MODEL UNKNOWN
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
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 Key4334258
Report Number1644487-2014-03341
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2014
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? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/21/2016
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 TREATMENT DATA
Date Received: 12/16/2014 Patient Sequence Number: 1
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