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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 04/12/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was initially reported that the patient's generator could be easily moved. At the time of the initial evaluation, the surgeon decided it was not medically necessary to proceed with surgery to address issues with the device migration. A non-absorbable suture was used to secure the generator at the time of the last generator replacement surgery. A subsequent report from the patient on (b)(6) 2016 indicated that she was actually proceeding with surgery. Further information indicated that there issues with seepage from the chest wound and device migration and protrusion. Follow up after her report indicated that her vns system was fully removed on suspicion of infection following a visit to the er and hospital admittance, and she was subsequently released from the hospital. Information received from the explanting surgeon's office confirmed that the patient's system was fully removed. The patient was admitted in-patient on (b)(6) 2016. The generator was reportedly extruding through a dehiscence wound. The generator was removed on a suspected infection in the chest. The lead was also removed to allow for full recovery, although there was no suspicion of infection in the neck. An antibiotic was prescribed. The pathology report for cultures showed negative or negligible for all tests, and showed no growth in culture media. The suture had to be cut for generator removal, indicating it was still intact before explant. No further information was given on potential causes or contributing factors to the device migration, protrusion, or extrusion. The explanting facility does not return explanted products per their internal policy, so return of the removed devices is not expected. The generator device history record was reviewed and found all specifications were met prior to distribution, and the generator was sterilized prior to distribution.

 
Event Description

Clinic notes were received with information on the patient's medical history. Some conditions were identified that may limit blood supply to certain regions of the body and contribute to wound healing difficulties. The surgeon did assess that he patient did not have risk factors for skin deterioration. However, his awareness of the patient's past medical history was uncertain. No additional pertinent information has been received to date.

 
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Brand NamePULSE GEN MODEL 105
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 Key5688800
Report Number1644487-2016-01168
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 05/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/09/2017
Device MODEL Number105
Device LOT Number203263
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/16/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/09/2015
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: 05/31/2016 Patient Sequence Number: 1
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