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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2019
Event Type  malfunction  
Event Description
During the patient¿s initial implant surgery, it was reported that when turning the hex setscrew there were no torque clicks heard indicating a secure connection between the generator and lead.The surgeon reported turning the hex setscrew until the setscrew would no longer turn.The surgeon then proceeded to remove the hex setscrew and noted that the protective cover and o-ring seal had come out of the generator and remained inserted in the hex setscrew.It was noted that the detached component then fell to the ground.It was reported that the surgical technician had handed the generator to the surgeon with the hex setscrew already inserted in the generator prior to attempting pin insertion and securing.It was noted that another generator was used and the surgery was successfully completed.A review of the generator's device history records was performed and revealed that the generator passed quality control inspection prior to distribution.The device has been received by the manufacturer, but product analysis has not been completed to date.No other relevant information has been received to date.
 
Event Description
Generator analysis was completed on the returned generator.A cause could not be determined for the detachment of the septum plug as it was not returned for analysis, but the header septum cavity met the required specifications.Not being able to torque the setscrew was not duplicated in the product analysis (pa) lab with the generator and returned torque wrench.The torque wrench secured the bench setscrew onto the bench lead (that was inserted to the returned pulse generator header) (the returned torque wrench made audible clicks) and extracted the bench setscrew from the negative connector block of the returned pulse generator with no issues (lab conditions).The generator worksheet was received and there were no issues observed.In the data downloaded from the generator, it was noted that the prechange impedance was high on the date of surgery and the product was opened but not used, thus the high impedance does not indicate a device malfunction.No other relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key9535533
MDR Text Key176547388
Report Number1644487-2019-02530
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/05/2020
Device Model Number106
Device Lot Number204641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received01/23/2020
Supplement Dates FDA Received02/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age43 YR
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