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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44 LEAD KIT, 90CM LENGTH SCS PADDLE LEAD

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ABBOTT MEDICAL LAMITRODE 44 LEAD KIT, 90CM LENGTH SCS PADDLE LEAD Back to Search Results
Model Number 3262
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Seizures (2063); Swelling (2091)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The results/ method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

It was reported that the patient¿s lips swell and have lesions with stimulation on. Additionally, the patient experienced seizures after passing through a security machine. As such, surgical intervention may take place to address the issues.

 
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Brand NameLAMITRODE 44 LEAD KIT, 90CM LENGTH
Type of DeviceSCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10928197
MDR Text Key218956533
Report Number1627487-2020-48397
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2014
Device MODEL Number3262
Device LOT Number3593615
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/18/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 12/01/2020 Patient Sequence Number: 1
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