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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 PADDLE LEAD
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ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD Back to Search Results
Model Number 3288
Medical Device Problem Code Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/22/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
Related manufacturer report number 3006705815-2020-32988.It was reported that the patient experienced ineffective therapy.As a result, surgical intervention took place wherein the system was explanted to address the issue.
 
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Brand Name
LAMITRODE 88 LEAD KIT, 60CM LENGTH
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10945367
Report Number1627487-2020-48384
Device Sequence Number2820246
Product Code LGW
UDI-Device Identifier05414734406307
UDI-Public05414734406307
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/03/2020
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 Health Professional
Device Expiration Date01/15/2020
Device Model Number3288
Device Catalogue Number3288
Device Lot Number6266505
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2020
Initial Report FDA Received Date12/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SCS IPG
Outcome Attributed to Adverse Event Other;
Patient Weight54
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