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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 02/23/2011
Event Type  Injury  
Event Description

It was reported that the patient was experiencing constant burning at her generator site as well as a shooting pain into the back of her head, hot flashes, and trouble breathing when her device would go off. This started following her recent replacement in (b)(6) 2011. The patient was told that this may be due to a lack of fatty tissue and possible scarring. The patient has been referred for a generator, and possible lead replacement. Attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received indicating that the patient's painful stimulation started following her generator being programmed back on in (b)(6) 2011. During stimulation, the patient experienced pain in left side of neck that proceeded to back of her head. She also noted more pain during magnet activation. She does; however, have seizure control. The patient's settings were provided and diagnostics were also run with ok results, however, no specifics were provided. The physician then lowered the patient's signal frequency to 20hz and pulse width to 250usec. The patient's magnet mode pulse width was also adjusted to 250usec. Diagnostics were repeated and tested ok. The patient was able to tolerate both normal stimulation and magnet stimulation following these adjustments and stated it was much better. The patient also complained of chest discomfort at generator site which the physician felt it was due to scar tissue and not stimulation related. The change in patient settings was performed for patient comfort, and no other interventions are planned at this time.

 
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Brand NamePULSE GEN MODEL 103
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2351767
Report Number1644487-2011-02874
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number103
Device LOT Number2862
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/13/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2010
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: 11/29/2011 Patient Sequence Number: 1
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