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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 30CM LENGTH; PERCUTANEOUS LEAD
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ABBOTT MEDICAL OCTRODE LEAD KIT, 30CM LENGTH; PERCUTANEOUS LEAD Back to Search Results
Model Number 3183
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 03/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for evaluation.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported the patient's scs system lead was exhibiting high impedance.Surgical intervention was taken and the physician decided to remove the patient's scs system.
 
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Brand Name
OCTRODE LEAD KIT, 30CM LENGTH
Common Device Name
PERCUTANEOUS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11630400
Report Number1627487-2021-12964
Device Sequence Number17149314
Product Code LGW
UDI-Device Identifier05414734401692
UDI-Public05414734401692
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/07/2021
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 Date07/28/2014
Device Model Number3183
Device Catalogue Number3183
Device Lot Number3761150
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 03/22/2021
Initial Report FDA Received Date04/07/2021
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 Weight136
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