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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR
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LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR Back to Search Results
Model Number 102
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/10/2008
Event Type  Injury  
Event Description
Information was received indicating that a patient wanted their device removed.The patient indicated that they believed the device was providing stimulation even though it was programmed off.The patient's device had been programmed off in 2010 due to lack of efficacy concerns expressed by the patient.The surgeon's office indicated the patient had not been seen in years but communicated their desires on the phone.All attempts to the patient's psychiatrist for additional information have gone unanswered.No other relevant information has been received to date.
 
Event Description
It was reported that the vns was turned off in 2011.
 
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Brand Name
PULSE GEN MODEL 102
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key5984577
MDR Text Key55883623
Report Number1644487-2016-02154
Device Sequence Number1
Product Code MUZ
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2009
Device Model Number102
Device Lot Number017084
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 09/08/2016
Initial Date FDA Received09/28/2016
Supplement Dates Manufacturer Received09/09/2021
Supplement Dates FDA Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
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