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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 12/13/2012
Event Type  Injury  
Event Description

Reporter indicated that during a ventral hernia repair surgery, a vns patient had an episode of bradycardia. The patient did not have a history of cardiac events, but the patient's father did have a history of cardiac events. The patient has pre-existing medical conditions of hypertension, depression, asthma, gerd, and tmj. The arrhythmia experienced was bradycardia; normal heart rate was 72, during event it was 39. Preoperative bp was 128/74, bp during event was 56/27 at the lowest. The vns generator was programmed on for the surgery. Interventions taken for the intraoperative bradycardia event were done to preclude a serious injury. The bradycardia has not recurred. Follow up with the reporter revealed '"pt presented for ventral hernia repair on (b)(6) 2012. Pt had eventful preoperative course, and no issues with induction of anesthesia. 1 hour into the case, during extensive lysis of adhesions in the abdomen [using electrocautery], the patient became profoundly bradycardic and hypotensive. Pt's anesthetic was decreased and he was given 100% o2, phenylephrine 600 mcg total, glycopyrrolate 0. 1 mg, atropine 0. 8 mg, calcium 0. 5 mg, magnesium 1 gm, and a total of 1. 7 mg epinephrine over the course of about 30 minutes during the severe bradycardia. A magnet was also placed over the [vns] device intraoperatively and transcutaneous pacing was used during the event. The case was aborted and the patient was subsequently extubated and taken to pacu and then the icu for overnight monitoring. He experienced no abnormal sequelae and returned several weeks later for the procedure without complication. " it was felt the combination of the extensive electrocautery used and the vns stimulation may have caused the bradycardia event per the reporter.

 
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Brand NamePULSE GEN MODEL 102
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3023649
Report Number1644487-2013-00835
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2007
Device MODEL Number102
Device LOT Number014188
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/28/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2005
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: 03/27/2013 Patient Sequence Number: 1
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