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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH SCS LEAD

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ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3288
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Device 2 of 2. Reference mfr. Report#: 1627487-2020-33244. It was reported the patient began to receive ineffective therapy after a car accident occurred. Allegedly, the patient's ipg and lead were found to have been disconnected from each other following the car accident. As a result, the patient decided to have their scs system explanted.

 
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Brand NameLAMITRODE 88 LEAD KIT, 60CM LENGTH
Type of DeviceSCS 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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10781148
MDR Text Key214474136
Report Number1627487-2020-33245
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2014
Device MODEL Number3288
Device Catalogue Number3288
Device LOT Number3590609
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 Received12/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2012
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: 11/03/2020 Patient Sequence Number: 1
Treatment
MODEL: 3788
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