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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEAD MODEL 303
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LEAD MODEL 303 Back to Search Results
Model Number 303-30
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Neck Pain (2433)
Date of Event 09/28/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Patient was referred to surgery to have their lead loosened due to reported tightness when turning their head.No known surgical intervention has occurred to date.No other relevant information has been received to date.
 
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Brand Name
LEAD MODEL 303
Common Device Name
LEAD
MDR Report Key12739691
Report Number1644487-2021-01522
Device Sequence Number17146881
Product Code LYJ
UDI-Device Identifier05425025750122
UDI-Public05425025750122
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
P970003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date (Section B) 11/02/2021
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
Operator of Device Lay User/Patient
Device Expiration Date12/03/2017
Device Model Number303-30
Device Lot Number3811
Was Device Available for Evaluation? No
Event Location Other
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date11/02/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured12/05/2013
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age41 YR
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