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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/22/2010
Event Type  Injury  
Event Description

It was reported that high lead impedance was received at a follow-up appointment with the treating neurologist. The neurologist indicated through a clinic note that the pt's generator tends to shift position and migrate into the axilla. He states that it has made it hard to interrogate and adjust and also hard to use during seizures to try to stop seizures. The last known good system diagnostics per a clinic note were from (b)(6) 2010 and were ok/ok/2/no. The pt was referred for generator and lead replacement surgery due to both high impedance and migration of the generator. Pre-op system diagnostics showed 7/limit/high/no and the pt's settings were 1. 5/30/250/30/3. A company representative present at the time of surgery indicated that the generator was more difficult to locate due to the pt's large size and the generator's location under some breast tissue. However, once it was located, the company representative was able to interrogate it on the first attempt. The surgeon opened the chest pocket during surgery, took out the generator and a portion of the lead came out with it. Moreover, the generator was not secured down in the pocket and the lead looked to be twisted. The surgeon was of the opinion that since the generator was not sutured down, the pt was moving it around and twisting it ultimately breaking the lead. Surgeon elected to perform a full revision. The old leads were cut at the nerve. Outside of the pocket diagnostics with the new system resulted in ok impedance/1692 ohms/10yrs. Inside the pocket diagnostics resulted in ok impedance/1521 ohms/10yrs. Nonetheless, communication difficulties were still present with the new generator and were likely due to the pt's physique. Good faith attempts to obtain the explanted devices have been unsuccessful to date.

 
Manufacturer Narrative

Conclusions - device failure occurred, but did not cause or contribute to a death or serious injury.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1867677
Report Number1644487-2010-02269
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number102
Device LOT Number009597
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2003
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: 10/08/2010 Patient Sequence Number: 1
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