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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
Device Problem Patient-Device Incompatibility
Event Date 08/24/2011
Event Type  Injury  
Event Description

It was reported that the patient was experiencing an allergic reaction to the metal used in the vns. Device explant was required, however the date of explant is currently unknown. Attempts for additional information have been unsuccessful to date.

 
Event Description

Additional information was received from a nurse with the surgeon's office indicating that the issue was first identified on (b)(6) 2011. The patient's home health nurse reported to the surgeon's office that the patient's wound was draining yellow purulent fluid. At that time, the patient was admitted to the hospital. Manipulation is not suspected as the patient is handicap and cannot reach her chest or generator site. The surgeon felt that issues were caused by tissue deterioration from an allergic reaction to the generator. Cultures were taken of the wound site and were found to be negative for growth. The lead and generator were both explanted on (b)(6) 2011. After the explant, the patient was sent home on antibiotics. The patient was then seen again on (b)(6) 2011 as her wound had re-opened and was again draining fluid. The patient was put on another dose of antibiotics however cultures were not taken. The nurse indicated that if the infection did not resolve they may have to admit the patient and administer stronger (intravenous) antibiotics to try to resolve the infection. There are currently no plans for replacement, however the surgeon did indicate that if they did chose to re-implant in the future, they may chose a different implant location. The nurse indicated that the issues were solely isolated to the chest area with no problems or infection in the neck. When the patient was seen on (b)(6) 2011, the neck incision was healing with no issues. The patient's generator model and serial number were also provided by the surgeon's office. The device history record was reviewed for the patient's generator and sterility was confirmed prior to shipment. During the follow-up with the nurse on (b)(6) 2011, it was reported that the patient's lead was extruding through the patient's chest wall. This event is reported under mdr number: 1644487-2011-02717.

 
Event Description

On (b)(6) 2012 an operative report from the day of surgery was received and indicated that the patient had "breakdown of her wound and then some drainage". She was not having a fever. The patient's generator and lead were explanted at that time and it was indicated that the tissue quality was "quite poor". It was also noted that hardware could be seen through the wound. It is unclear if the hardware that could be visualized was the generator or the lead. Additional information was then received on (b)(4) 2012 that the patient was healed and ready for implant, which then occurred on (b)(6) 2012.

 
Event Description

Analysis was completed, and no anomalies were identified with the generator. The generator was left on after explant, and the generator was pulse disabled upon receipt. A battery life calculation estimated 0 years remaining battery life.

 
Event Description

The explanted generator was received on (b)(4) 2015. Analysis has not been completed to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key2293177
Report Number1644487-2011-02447
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2013
Device MODEL Number103
Device LOT Number2964
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2011
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: 10/13/2011 Patient Sequence Number: 1
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