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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 12/13/2011
Event Type  Injury  
Event Description

On (b)(6) 2012, a vns implanting surgeon's nurse reported that the vns patient was complaining of pain in the left axillary/pectoral area and stating that the vns moves occasionally. The patient has had physical therapy to see if it would help with the discomfort but it did not. The patient was going to have surgery to either reposition or replace the battery. The nurse stated that the patient first reported the pain on (b)(6) 2011. The patient had surgery on (b)(6) 2012 and the surgeon just repositioned the generator and did not replace it. The operation notes from the surgery reveal that the patient has been experiencing this pain at the generator site over the past several months. The pain was exacerbated by movement at her shoulder. The surgeon stated that x-rays showed no evidence of malposition or break in the wire and that diagnostics show no evidence of functional problems. Because of the pain, the patient underwent reposition of the generator. After the generator was repositioned, diagnostics were still within normal limits. Attempts for additional information from the surgeon were made but no further information has been received to date. The implanted product information has been requested from the hospital but has not been received.

 
Event Description

On (b)(6) 2012 the patient's implanted product information was received from the medical records department of the hospital the patient was implanted in.

 
Manufacturer Narrative

Additional information was received regarding the product information therefore updating the information reported on the initial report.

 
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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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2468877
Report Number1644487-2012-00517
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2012
Device MODEL Number103
Device LOT Number2846
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2010
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: 02/27/2012 Patient Sequence Number: 1
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