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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 06/17/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient was admitted to the hospital due to status epilepticus. The patient had previously been seizure free. At the hospital, the patient¿s device showed high impedance. The output current was decreased but the high impedance did not resolve. The patient¿s device was subsequently disabled. X-rays were provided to the manufacturer for review. The lead connector pin could not be confirmed to be fully inserted into the generator connector block. The patient underwent surgery on 07/11/2014. The surgeon was able to disconnect the lead pin from the connector block without loosening the setscrew. The surgeon re-inserted the lead pin into the connector block and the high impedance resolved (impedance value - 2453 ohms). The surgeon elected to replace the patient¿s generator during the procedure. The explanted generator has not been returned to date.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, complete lead pin insertion cannot be confirmed.

 
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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 Key3977523
Report Number1644487-2014-01922
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/09/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device MODEL Number105
Device LOT Number202851
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/09/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2014
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: 08/04/2014 Patient Sequence Number: 1
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