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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 01/01/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.

 
Event Description

Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

 
Event Description

Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 103
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 Key5402897
Report Number1644487-2016-00195
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 01/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL Number103
Device LOT Number202504
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/21/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/20/2013
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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