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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 01/01/2013
Event Type  Malfunction  
Event Description

Follow up with the physician found that the physician tried the magnet on the patient and there were no muscle spasms, and therefore did not believe they were related. On (b)(6) 2013, the patient reported that she had a seizure the night prior and went to the ed. After being released from the ed, they patient was called back and told that the cat scan showed a tumor, cyst, or spot on her brain. Per the patient, the leads were on backwards and she was having a lot of gi problems. Follow up with the physician found that the patient was no longer his patient as of the last six to seven months. However, the patient was under the physician's care as of (b)(6) 2013. The patient's vns was found to be in proper working order and of proper function. Diagnostics on each visit were found to be appropriate as of the last visit on (b)(6) 2013. The patient has had seizures on and off since the initiation of her care in 2011. On her visit of (b)(6) 2013, the patient stated that she had a seizure the day previous on (b)(6) 2013. Over the last several months, the patient's vns has been adjusted. Her output has been increased. Her medications have also been adjusted appropriately. The physician received a fax from the patient on (b)(6) 2013 stating, "the last medication and vns adjustments that you made worked perfectly and i haven't had a seizure since my last appointment. " her last appointment before (b)(6) 2013 was on (b)(6) 2013. The patient alleges that has had increased seizures for six to seven moths; however, her seizures have been somewhat sporadic. The patient's chart also alludes that she has had a complaint of abdominal spasms, possibly not related to her seizures. The physician's inquiry did not reveal any relationship of these spasms to her vns device whatsoever, however, he stated that he is now aware that they patient told the manufacturer that her spasms are related to her magnet use. When the magnet diagnostics were performed in the physician's office on the patient's last visit of (b)(6) 2013, the patient had no evidence for abdominal spasm visually perceived by the physician nor complaint of the spasm at that time, verbally complained by the patient. No cause or contributory programming changes, medication changes, or factors that the physician is aware of seem to increase the patient¿s seizures. In summary, the patient¿s vns device appears to be working properly. There appears to be no connection between the patient¿s vns device and her complaint of increased seizure events. No additional information has been provided.

 
Event Description

On (b)(6) 2013, the patient reported that she has been having some "bizarre" symptoms lately and that she has been having an increase in seizures over the past six to seven months. She stated that she has about one per day. The patient is also experiencing muscle spasms in her abdomen on the left side that is affecting her bowel movements. On (b)(6) 2013, the patient reported that she is having issues with her magnet not helping her stop her seizures and that she is experiencing muscle spasms in her diaphragm and abdomen. The patient is not sure if the muscle spasms are related to her vns, but has noticed the spasms occur when she uses her magnet. Follow up with the physician found that the patient was seen in her office on (b)(6) 2013. The physician ran diagnostics and everything was ok. The physician stated that she swiped the patient's magnet and the patient was able to feel stimulation. There were no muscle spasms or any issues with the patient when she received the magnet stimulation. Per the physician, the patient appeared anxious, so it was discussed if she should see someone for her anxiety. No additional information has been provided.

 
Event Description

Clinic notes dated (b)(6) 2013 note that the patient suffered a seizure while driving in (b)(6) 2013 and rear-ended another vehicle at 70 ml/h. It was noted that since then the patient's seizures have significantly worsened. It was noted that the patient's output current was reduced and she was doing somewhat better. It was noted that device diagnostics showed lead impedance "ok". The patient was sent for x-rays of the chest and abdomen. Chest x-ray report indicated that the x-ray did not identify any obvious lead fractures. Abdomen x-ray report indicated that the impression was a negative exam.

 
Event Description

It was reported that the patient underwent generator and lead replacement surgery. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the returned lead and generator was completed on (b)(4) 2014. Analysis of the returned generator revealed no anomalies, and the device performed according to specifications. The output signal of the generator was monitored for more than 24-hrs and the results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead revealed that, other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3283359
Report Number1644487-2013-02389
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number2839
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/30/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/28/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/11/2010
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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