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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 10/04/2013
Event Type  Injury  
Event Description

Initially, it was reported that the patient has been experiencing difficulty swallowing and shortness of breath. The patient reported that this is more often than not. The patient also reported that it feels like the device is shocking her from the generator to up under her tongue. The patient reported that taping the magnet over the generator was attempting, but was too painful. The patient also reported that the generator feels like it is slipping down into her armpit. The patient reported that the device has not been checked in three to four years. The patient was later seen by a surgeon and surgery was scheduled. It is unknown whether or not surgery occurred as planned. Attempt to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

 
Event Description

Further follow-up revealed that the patient's surgery occurred as planned on (b)(6) 2013. Only the generator was explanted. It was reported that the surgery was for patient comfort. It was reported that the patient was not using vns therapy as prescribed because the patient wasn't being followed by a psychiatrist and having the device programmed as needed. No known causal or contributory factors preceded the onset of the events. It is unknown if a non-absorbable suture was used to secure the generator to the fascia during the implant surgery. Attempts to have the generator returned for analysis have been unsuccessful to date.

 
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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 Key3472747
Report Number1644487-2013-03497
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number013620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/19/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2005
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: 11/15/2013 Patient Sequence Number: 1
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