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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problems Difficult to Insert; Mechanical Problem
Event Date 09/12/2018
Event Type  Malfunction  
Event Description

It was reported a company representative, that a generator immediately did not look right to the surgeon after being taken out of the packaging for an implant surgery. The septum plug looked frayed and did not look right initially the surgeon could not get the lead to go past the first connector block, but eventually he was able to use the hex screw driver to get the lead in. Then the lead pin tip would not go past the second connector block. The surgeon indicated that the generator and lead connection didn't look right. Impedance was ok at 2030 ohms but they had hesitations about using the generator. The surgeon had reportedly done many surgeries in the past. It was noted that he had tried irrigating the lead cavity. The attending company representative indicated that the surgeon probably tried to use the hexscrew 20 times. The surgeon decided to use a new generator. The manufacturer's device history records of the suspect generator were reviewed. The generator passed final quality and functional specification prior to release. The suspect product was received but product analysis on it has not been completed to date. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7939457
Report Number1644487-2018-01778
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number106
Device LOT Number5658
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2018
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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