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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 05/04/2011
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits. The manufacturer's consultant reported that she made good faith attempts to obtain additional information from the physician concerning the patient's adverse events. The physician reported that the patient is doing well after the generator replacement and that all the patient's issues have resolved except for her pre-existing conditions.

 
Event Description

Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.

 
Manufacturer Narrative

(b)(6). The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.

 
Manufacturer Narrative

The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.

 
Event Description

Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.

 
Event Description

On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing pain in their chest with stimulation. The patient said the pain is sharp and is at the incision location of the generator site. The patient was also reported to be experiencing sleep apnea. The patient was recently evaluated by an ear, nose, and throat physician who discovered that the patient has paralysis of the left vocal cord in the median position which is causing the patient dyspnea and coughing. The patient says that the vns does help with seizures and that if the vns is off she will have grand mal seizures. A 14-system review of the patient's systems was done by the physician and the patient was found to have asthma. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. The physician reported that if the patient's symptoms persist, it may be necessary to explore and possibly replace the generator as she gets benefit from a functioning system. Clinic notes dated (b)(6) 2011 report that the patient has had an increase in seizure frequency over the past few months. The patient has also noticed an increased pain in her left chest in the area of the generator pocket. Diagnostics were performed which revealed no malfunction; specifics were not provided. The physician reported that given the patient's pain in her chest, as well as decreased efficacy within the past 3 months, he is referring the patient for prophylactic battery replacement. Additional clinic notes were received from the physician dated (b)(6) 2011 which revealed that the patient was having an increase in spells. The patient went to the epilepsy monitoring unit and these were non-epileptic. The patient also feels that her asthma has worsened. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. A battery life calculation was performed with the patient's programming history and it revealed negative years until eri = yes. The patient went for battery replacement surgery on (b)(6) 2011. The manufacture's consultant reported that she has the explanted generator and will be sending it back for product analysis but it has not yet been received. When additional information has been received, it will be reported.

 
Manufacturer Narrative

 
Event Description

Additional information was received on (b)(6) 2011 when the explanted generator was returned for product analysis that was completed on (b)(6) 2011. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. 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. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

 
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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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2212668
Report Number1644487-2011-01875
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2006
Device MODEL Number102
Device LOT Number010960
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/17/2011
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/05/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2004
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: 08/16/2011 Patient Sequence Number: 1
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