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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 10/01/2012
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that this vns patient underwent surgery in (b)(6) 2013 to check the state of the vns system. No anomalies were found. The generator was moved to a different place inside the chest pocket. The generator was turned back on 10 days after the surgery, and it was noted that the patient did withstand an output current up to 1ma, but 1. 50ma appeared to cause painful stimulation (1. 25ma was not tested). The patient stated that painful stimulation seems to be increased or triggered in certain positions of the patient, especially when he keeps his head bent to one or other side. Review of programming history shows that the device was disabled on (b)(6) 2012 and programmed on (b)(6) 2013. Painful stimulation was initially reported in (b)(6) 2012; however, the event began in (b)(6) 2012 when the output current was at 1. 25 ma. System diagnostics showed that the lead impedance was within normal ranges, with dcdc = 3, and normal mode diagnostics returned impedance within normal ranges too, with dcdc = 5. The generator was disabled. Further information was received stating that the pain started in (b)(6) 2012. No causal or contributory programming or medication changes preceded the beginning of the painful stimulation. No trauma was noted, though the patient reported that the first painful shocks occurred after a physical effort (he raised something heavy). No other interventions were planned at that time. X-rays were provided for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No acute angles or clear breaks were found in the parts of the lead that were visible. Attempts to obtain further information were unsuccessful.

 
Manufacturer Narrative

Review of programming history.

 
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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 Key3075477
Report Number1644487-2013-01154
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number102
Device LOT Number201906
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/27/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2011
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: 04/24/2013 Patient Sequence Number: 1
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