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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 90CM LENGTH; SCS PADDLE LEAD
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ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 90CM LENGTH; SCS PADDLE LEAD Back to Search Results
Model Number 3268
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 07/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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
It was reported during the patient's ipg replacement (manufacturer reference number: 1627487-2021-15704) the lead was replaced due to high impedances.Therapy was restored post-op.
 
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Brand Name
LAMITRODE S-8 LEAD KIT, 90CM LENGTH
Common Device Name
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12225807
Report Number1627487-2021-15876
Device Sequence Number5127911
Product Code LGW
UDI-Device Identifier05414734402194
UDI-Public05414734402194
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/26/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date08/28/2014
Device Model Number3268
Device Catalogue Number3268
Device Lot Number3776062
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 07/14/2021
Initial Report FDA Received Date07/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight68
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