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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/15/2014
Event Type  Injury  
Event Description

It was initially reported that the patient had their vns explanted. After the explant, the patient picked at the incision and opened the pocket. There was nothing implanted in the patient at that time of the incision being picked open.

 
Event Description

Additional information was received that product analysis was completed on the lead. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. The report issue found with the lead was reported on medwatch 1644487-2014-02836.

 
Event Description

Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014. Patient's stitches were taken out and replaced with steri-strips. The patient's chest incision was reported to be open with yellow drainage from it. Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.

 
Manufacturer Narrative

Evaluation not related to event.

 
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Brand NamePULSE GEN MODEL 102
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 Key4147147
Report Number1644487-2014-02562
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/23/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number102
Device LOT Number202575
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/13/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/11/2013
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: 10/07/2014 Patient Sequence Number: 1
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