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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 06/22/2012
Event Type  Injury  
Event Description

It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.

 
Event Description

It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2662284
Report Number1644487-2012-01824
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2013
Device MODEL Number103
Device LOT Number3145
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/23/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2011
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: 07/19/2012 Patient Sequence Number: 1
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