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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 04/04/2014
Event Type  Malfunction  
Event Description

It was reported that device diagnostics resulted in high impedance (>10,000 ohms) on (b)(6) 2014 and again on (b)(6) 2014. It was reported that x-rays did not show an obvious lead break. It was reported that device diagnostics during generator replacement in (b)(6) 2013 were within normal limits (2640 ohms). There was no trauma or patient manipulation that is believed to have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. Review of x-rays identified that the lead pin did not appear to be fully inserted into the generator header. Clinic notes dated (b)(6) 2014 note that device diagnostics showed impedance value - >10,000 ohms. It was noted that the patient suffered a bad fall approximately one months prior and that the patient has a tendency of striking his fists against his upper chest. The patient also uses his fingers to tug on his clavicles. It was noted that any of these activities may have dislodged the lead pin or produced a fracture in the lead. The patient was referred for surgery. During surgery, the lead pin was removed and then reinserted into the generator header. Device diagnostics were then within normal limits. The high impedance is related to the lead pin not being fully inserted into the generator header.

 
Manufacturer Narrative

Adverse event or product problem, corrected data: previously submitted mdr indicated that the event was only a product problem; however, this should have also been reported as an adverse event. This report is being submitted to correct this information.

 
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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 Key3793934
Report Number1644487-2014-01210
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/30/2014
Device MODEL Number105
Device LOT Number202224
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/04/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2012
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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