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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 09/17/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, additional information was received indicating that the patient had been seen three weeks prior and none of the previously reported symptoms had been observed. Per the patient they had all resolved. Follow up with the physician's office indicated that the patient's seizures were well controlled with vns. It was indicated that the pain was believed to be caused by stimulation as it correlated with on times. This pain then caused the patient to vomit. The patient went to the er on (b)(6) 2012 for these symptoms. They met her in the er and turned the device off. When the device was disabled everything resolved. It was indicated that the device may have been stimulating irregularly. The last programming and medication changes occurred in (b)(6). It was also indicated that the patient had no medical history of any of the events and that everything was fine from (b)(6). The physician's office was uncertain if there had been any manipulation or trauma to the device. Attempts for additional information have been unsuccessful to date.

 
Event Description

A nurse practitioner reported to our field representative that they had a vns patient who had their device implanted in (b)(6). The patient was doing fine with vns, up until 2 days ago, when the patient started complaining of excessive stimulation which then made the patient experience nausea and vomiting. The physician recommended to tape the magnet over the device. The patient did that, which was fine for about an hour, but then started experiencing excessive stimulation again after that. The patient had their vns disabled on (b)(6) 2012. The patient described that when she first started to experience this, she initially taped the magnet over the device and for about 1. 5 hours the device was completely off and she did not experience this. But after that 1. 5 hours, she started to feel nauseous again and vomited. Since disabling the device, the patient has had none of the same problems. The patient just has some minor soreness in her throat which appears to be residual. Diagnostics (normal, system, and magnet) and all the diagnostic results were ok, and within normal limits. The normal mode diagnostic showed communication ok/ lead impedance ok/ 3453 ohms /no. The patient's device is currently disabled, and prior to the disablement the settings were at: 0. 75 output current / 30 hz /500 pw / 30 seconds on time/5, minutes off time ,1. 0 ma / 60 seconds on time / 500 pw. The patient additionally reported that she is supposed to swipe her magnet every day, and after she did so yesterday ((b)(6) 2012) she began experiencing irregular stimulation that was going off anywhere from every 20 seconds to every 1. 5 hours. She was clear that the problems only occurred after she swiped the magnet. She stated that her stimulation is supposed to go off every 5 minutes for 30 seconds so she knew this was not right. The patient explained that with the erratic stimulation, she was experiencing pain at the back left side of her throat, and along with the pain she was vomiting, couldn't breathe, and her heart rate would increase to 150. As she was explaining this, she confirmed that the events were occurring with stimulation, aside from the vomiting that was a result of the pain. The patient reported that she had not had any medication or any external factors changes recently. She also confirmed that no trauma or manipulation had occurred prior to these events. The patient additionally reported on (b)(6) that after having vns implanted she was seizure-free for 4. 5 months, but last week had 2 tonic-clonic episodes. It is likely their device was disabled at this time. Therefore the patient was not receiving vns therapy. The patient's device may be kept off for a couple of weeks and the patient reevaluated to turn it program it back on at a later date.

 
Event Description

Additional information was obtained on (b)(6) 2012. It was indicated by the patient's neurologist that the anatomical location of the painful stimulation was left neck and the patient had no manipulation or trauma that could have caused or contributed to the painful stimulation. The physician indicated that he was unaware of the arrhythmia occurring and the patient was seen at an emergency for the arrhythmia. The patient had no prior history or family history of any cardiac events. Per the physician the patient did not experience any traumatic events or triggers prior to the onset of arrhythmia. The physician believes that patient's arrhythmia is not due to medication changes and has no information if the arrhythmia is related to vns therapy. On (b)(6) 2012, the patient's vns was irregularly going off as reported by the physician. The patient had a shocking sensation with very high intensity. The patient's device was turned off to preclude a serious injury. On (b)(6) 2012, the patient's device was turned back on and the programmed settings and diagnostic results appeared to be normal however the diagnostic test results were not provided. On (b)(6) 2012, the patient's device was reevaluated.

 
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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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2788235
Report Number1644487-2012-02626
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/19/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number103
Device LOT Number3145
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/19/2012
Event Location Other
Date Manufacturer Received12/21/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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