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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM SCS LEAD

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ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM SCS LEAD Back to Search Results
Model Number 3219
Device Problems Low impedance (2285); Migration (4003)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/24/2021
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated.

 
Event Description

It was reported that the patient¿s lead migrated. Diagnostics revealed low impedances. As such, surgical intervention took place on (b)(6) 2021 wherein the lead was repositioned back to the original location with additional suturing addressing the issue. Reportedly, therapy was restored post operatively.

 
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Brand NameLAMITRODE TRIPOLE 16 LEAD, 60 CM
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
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12355494
MDR Text Key267734079
Report Number1627487-2021-16498
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 08/31/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3219
Device Catalogue Number3219
Device LOT Number7320747
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 Received08/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/06/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/23/2021 Patient Sequence Number: 1
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