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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 03/11/2016
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2016 indicate that the patient is experiencing a noise in her ear. Additional information was received that the patient woke up on (b)(6) 2016 while sleeping and could hear static and high pitched sound in her ear. Her generator site was hurting and her brain was foggy. The patient then visited the nurse practitioner on (b)(6) 2016. During the visit, the nurse practitioner was testing the magnet by swiping it and the patient felt like getting electrocuted as she had never needed to use the magnet before. Patient had bruising and tenderness in the chest and vomited due to the magnet stimulation. The nurse practitioner noted that the magnet stimulation pulse width was at 500 usec, which was very high compared to the normal stimulation. So the magnet pulse width was decreased down to be the same as normal stimulation. Diagnostics were performed and were within normal limits. X-rays were taken afterwards and no issues were observed. Patient also mentioned that the generator moved around and that it has been a while since this started (prior to (b)(6) 2016). Since the shock with the magnet, patient felt that her heart would beat really fast. This happens about once a day at different times of the day and can last 10-30 min. This heart beat increase is not occurring necessarily with vns stimulation and the vns stimulation doesn't make it better or worse. She never had this happen before and there are no triggers that patient could find. Patient was referred for generator replacement due to end of service of the device battery prior to the occurrence of these events.

 
Event Description

Additional information was received from the treating nurse practitioner that the patient's chest pain, high pitched sound in ear, and "foggy" brain were not occurring with vns stimulation. No known causes or contributory factors were present. Patient's increased heart rate or palpitations and other events are suspected to be associated with the higher pulse width of the magnet mode stimulation. The pulse width of the magnet mode stimulation was decreased from 500 usec to 130 usec to match the pulse width of the normal mode stimulation. Per the medical profession, there was no device migration as she could not perceive any movement of the generator. The pain in the chest was not due to presence of device or migration. Patient has had her generator replaced since then on (b)(6) 2016 and is doing well. The explanted device has not been received to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
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 Key5549412
Report Number1644487-2016-00719
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012565
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2005
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: 04/06/2016 Patient Sequence Number: 1
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