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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.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
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Brand Name
LAMITRODE TRIPOLE 16 LEAD, 60 CM
Type of Device
SCS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12355494
MDR Text Key267734079
Report Number1627487-2021-16498
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734401821
UDI-Public05414734401821
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
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 Expiration Date01/05/2022
Device Model Number3219
Device Catalogue Number3219
Device Lot Number7320747
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight82
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