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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 04/08/2012
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2012 found that the patient had experienced "four episodes of limpness and unresponsiveness lasting up to 45 minutes," which was "completely atypical for her. " the patient's mother confirmed the change in seizure pattern on (b)(6) 2012 as she reported that the patient was experiencing incontinence during seizures which the patient had not prior to vns in 2007, and that recently the patient became unresponsive while experiencing seizures. The patient's mother also reported that the patient's seizures had increased in frequency; however, she stated that this frequency was the same frequency level the patient had prior to vns. The patient's mother reported that the patient had been to the emergency room three times in the past few months and that the "unresponsive" behavior started on (b)(6) 2012 while the incontinence had been occurring for the past eight months. Clinic notes dated (b)(6) 2012 further detail the patient's change in seizure pattern. The patient's unresponsiveness lasts 4-5 minutes. The patient also experiences clusters of eye rolling up fluttering, which leads to difficulty seeing. Nine of these events were experienced on (b)(6) 2012 from 0650 to 0745, and three more events were experienced while the patient was in school. In addition, it was noted on (b)(6) 2012 that the patient is in pain when using the magnet. It is unknown where this pain is located and how long it has been occurring. Clinic notes dated (b)(6) 2012 verify that the patient's seizures had become worse and that she was in the hospital that day due to the number of seizures. The physician states in the notes that he believes the patient needs a prophylactic battery replacement as the battery is greater than six years old and the rapid cycling settings the patient is set on is using up the battery more quickly. Notes dated (b)(6) 2012 again state that a vns battery change is needed, and the patient underwent replacement surgery on (b)(6) 2012. Attempts have been made for additional information; however, they have been unsuccessful. Attempts will be made for product return so product analysis can be performed. No additional information is available.

 
Event Description

Clinic notes dated (b)(6) 2012 indicate that the patient had about ten seizures per day, which was pretty good control for her. Clinic notes dated (b)(6) 2012 additionally noted that the physician was concerned about the recent episodes the patient had. The physician stated that the patient's mother told him that the patient is out of it for 45 minutes and can sleep up to 18 hours. Apparently a teacher at school thought the patient was faking this although the physician stated it is unclear to him how the patient could fake that length of sleeping. Per the physician, the patient does not typically have this type of seizure and this is a change for her, so before making medication adjustments, it was planned to take a 24 hours video eeg to see if there aware any changes from her last eeg which was several years ago. Clinic notes dated (b)(6) 2012 indicate that the patient was weaned off of topomax.

 
Manufacturer Narrative

Date of event, corrected data: incorrect date inadvertently written in initial mdr. Describe event or problem, corrected data: information from clinic notes inadvertently not included in initial mdr. Relevant tests/laboratory data, including dates, corrected data: information inadvertently not included in initial mdr.

 
Event Description

Follow up with the physician's office found that the patient's device was turned back on again on the same day of the surgery - (b)(6) 2012. The explanted device has been discarded/destroyed. No additional information has been provided.

 
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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 Key2858364
Report Number1644487-2012-03207
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number102
Device LOT Number016274
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2006
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: 12/05/2012 Patient Sequence Number: 1
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