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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 04/04/2013
Event Type  Injury  
Event Description

On (b)(6) 2013 this vns patient reported that her battery was low and that there had been no indication that it would occur. The patient was waiting to see a surgeon and had been experiencing pain, discomfort, and blackout spells. The patient reported experiencing aura-like sensation, stomach pain, urinary incontinence, tachycardia, and had blacked out once since generator had become depleted. Clinic notes dated (b)(6) 2013 stated patient reported that vns seemed to stop working on (b)(6) 2013. The patient attempted swiping the magnet several times on (b)(6) 2013, which only barely activated the vns device. The patient attempted a swipe on (b)(6) 2013, which produced tingling in the scalp and tachycardia almost instantly. The patient took 2 lorazepams and went to the emergency room. The patient had been prescribed potiga several months prior, but never started as the potential side effects scared the patient and the patient felt that seizures were under control. Additionally, the patient had obtained a bottle of clonazepam several months prior and overdosed on it while also taking regularly prescribed lorazepam on (b)(6) 2013. At the (b)(6) 2013 visit, the vns was successfully interrogated, programmed and diagnostics were performed. The results were provided. The patient was referred for vns replacement surgery. On (b)(6) 2013 the patient reported that she went to the emergency room the night of (b)(6) 2013 because of complications. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

 
Manufacturer Narrative

Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3106486
Report Number1644487-2013-01248
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015424
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received04/11/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2006
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: 05/10/2013 Patient Sequence Number: 1
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