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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 07/27/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that the surgeon had to implant the m 106 generator on the right chest of the patient on (b)(6) 2016 and that the heartbeat verification was unsuccessful. It is unknown if a pre-surgical evaluation was performed and if all the troubleshooting steps were completed. Attempts for additional relevant information were made but no additional relevant information was received.

 
Manufacturer Narrative

(b)(4). Serial #, corrected data: (b)(4). Initial mdr inadvertently did not list the product serial #. Lot #, corrected data: 203490. Initial mdr inadvertently did not list the product lot #. Expiration date (mo/day/yr), corrected data: 02/18/2017. Initial mdr inadvertently did not list the product expiration date. Device manufacture date (mo/day/yr), corrected data: 05/26/2016. Initial mdr inadvertently did not list the device manufacture date. (b)(4).

 
Event Description

Product information was received on 08/08/2016. A review of device history records for the generator shows that no unresolved non-conformances were found. The r-wave verification step was successful per the device history records. The generator is not a laser routed device. Additional relevant information has not been received to date.

 
Event Description

Additional information was received that the patient has the generator implanted in the right chest and electrodes implanted on left vagus nerve. The physician inquired if the placement of the devices would contribute to problems with the heart rate sensing of the m106 as the neurologist was unable to get the hb detection to perform. The patient¿s generator was implanted on the right since the patient has a pacemaker implanted on the left. Per labeling, the implant location of the model 106 pulse generator critically affects its ability to properly sense heart beats. Improper implant location and/or heartbeat detection sensitivity setting could (b)(6) impact r-wave detection performance results.

 
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Brand NamePULSE GEN MODEL 106
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 Key5890558
Report Number1644487-2016-01878
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 07/27/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2017
Device MODEL Number106
Device LOT Number203490
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/26/2016
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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