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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 06/18/2012
Event Type  Injury  
Event Description

Additional information was received from the treating neurologist which revealed that medical/surgical intervention was planned with regards to the migration and discomfort at the generator site due to patient comfort and not to preclude a serious injury. The outcome of the repositioning surgery was "good", per the physician. The lead migrated due to "body habitus" (patient physique), however details were not provided. No causal or contributory programming or medication changes precede the onset of the lead migration. X-rays of the patient's vns were taken but have not been received by the manufacturer to date. The x-ray report was provided by the physician which indicated that the patient "complained of pain in the region of the vns device. Also states that she feels the device has shifted. Exam was done for vns placement. " chest x-ray of (b)(6) 2012 and also compared to soft tissues of the neck x-ray of (b)(6) 2010. The vns generator reportedly appeared to have shifted slightly inferomedically relative to its position previously. The electrode coursing into the base of the left neck appears intact; however, it also appeared to have shifted slightly, per the report. Previously, it was overlying the 2nd rib and on (b)(6) 2012 appeared to have shifted interomedially and was overlying the left apex. It coursed into the base of the neck as previously.

 
Event Description

The patient had vns repositioning surgery on (b)(6) 2012. Further details were not available. Attempts for additional information have been unsuccessful to date. The clinic notes dated (b)(6) 2012, reported that the generator appeared to have shifted slightly inferomedially which was believed to have caused pain to the neck and left face area.

 
Manufacturer Narrative

 
Event Description

A registered nurse at the treating physician's office reported on (b)(6) 2012 to the company representative that the patient complained of left mid axillary pain and thought it was due to the vns having moved. A chest x-ray was ordered, and the nurse reported that it appears to have shifted slightly inferomedially. The electrode reportedly has moved as well. Previously, it was reported on (b)(6) 2012 from the surgeon's office that they were planning on seeing the patient for evaluation of the patient's reported complaint of pain at the generator site. The neurologist's office referred the patient to the ent to see if the complaint she had was related to another reason other than vns. An ent evaluated the patient and concluded that there may be generator migration which may be causing the discomfort at the generator site. Clinic notes dated (b)(6) 2012 reported that the patient still remains with difficulty tolerating the device. She has intermittent dysphonia, pain in the neck radiating to the ear and the mandible and sometimes problems swallowing. The previous visit they discussed referral to ent for evaluation, and the patient requested for the referral. The referral requested for evaluation of the neck, ear and mandible pain related to vns to see if there is a need to revise the area where the device is placed. On the previous visit on (b)(6) 2012, the patient presented with no side effects. Follow up with the referring neurologist revealed that the pain was first observed on (b)(6) 2010. The dysphonia and trouble swallowing are reportedly recurring problems noticed in (b)(6) 2010. The patient was advised to have x-rays taken and to be evaluated by a neurosurgeon. No patient manipulation or trauma occurred that is believed to have caused/contributed to the events, and no causal or contributory changes preceded the onset of the events either. The neurologist reported that the pain, trouble swallowing, and dysphonia are associated with stimulation. The patient does not have a pre-existing medical history of having difficulty swallowing prior to vns. Although surgery was still being considered in (b)(6) 2012, it had not been scheduled to date due to the physician wanting the patient undergo imaging studies. Attempts for additional information from the surgeon and treating physician's office have been unsuccessful to date. Although surgery is likely, it has not occurred 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 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2792685
Report Number1644487-2012-02640
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2011
Device MODEL Number102
Device LOT Number2555
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/30/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/02/2010
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: 10/16/2012 Patient Sequence Number: 1
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