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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
Event Date 06/04/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (5348 ohms). The generator was programmed off and x-rays were taken. It was reported that the patient has been digging at the incision site since implant. It was reported that the patient was recently implanted. The patient was seen by the physician again and device diagnostics were performed which resulted in impedance values from 5200 ohms to high in the 5000 range. The physician indicated that the x-rays were ok. X-rays were sent to manufacturer for review. Based on the x-rays received, it appears that the lead pin not being fully inserted may be the cause of the device¿s high impedance. There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Surgery is likely, but has not been performed to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

 
Event Description

It was reported that the patient underwent revision surgery at which time the lead pin was reinserted into the generator header. It was reported that device diagnostics after the lead pin was reinserted was within normal limits (2888 ohms and 2740 ohms).

 
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Brand NamePULSE GEN MODEL 105
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 Key3910595
Report Number1644487-2014-01673
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number105
Device LOT Number3817
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/11/2013
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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