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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/16/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported by a physician that a patient was experiencing painful stimulation. Diagnostics were reportedly okay. The patient currently had placed the magnet over the device to disable stimulation. It was stated the pain began suddenly. From what the patient told him, it was not associated with increase in settings. The plan was to turn off the generator and perform revision surgery. Follow-up from the case manager provided the patient may have had trauma to the neck. Clinic notes were received from a visit on (b)(6) 2017. Within the notes it was provided that the patient has been experiencing shortness of breath and numbness and tingling in the left side of her throat where the leads run through. She feels as if the stimulator is going off all the time. The patient stated she never had similar problems with her previous vns. Diagnostics were provided as ok and battery life was stated as ¿green¿. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Full revision surgery occurred. The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Analysis was completed for the returned generator. Proper functionality of the pulse generator to provide appropriate programmed output currents was verified. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 953 volts and shows a low battery indicator had not been set. The downloaded data revealed that 34. 056% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portion. The electrodes were not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device.

 
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Brand NamePULSE GEN MODEL 105
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6484561
Report Number1644487-2017-03604
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/04/2016
Device MODEL Number105
Device LOT Number203189
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2014
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: 04/11/2017 Patient Sequence Number: 1
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