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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR
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CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
Event Date 06/05/2014
Event Type  Injury  
Event Description
The patient's device was explanted due to lack of efficacy and pain.The explanted suspect device has not been received to date.No further relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 103
Type of Device
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key12681954
MDR Text Key277907454
Report Number1644487-2021-01459
Device Sequence Number1
Product Code MUZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 10/22/2021
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 Date09/24/2015
Device Model Number103
Device Lot Number3773
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 09/27/2021
Initial Date FDA Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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