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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; PERCUTANEOUS LEAD
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ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; PERCUTANEOUS LEAD Back to Search Results
Model Number 3189
Device Problem Low impedance (2285)
Patient Problem Inadequate Pain Relief (2388)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
Related manufacturer reference number: 1627487-2021-12942.It was reported the patient experienced ineffective stimulation due to low impedances.Surgical intervention took place wherein the leads were explanted and replaced.Effective therapy was established.
 
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.
 
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Brand Name
OCTRODE LEAD KIT, 90CM LENGTH
Type of Device
PERCUTANEOUS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11618813
MDR Text Key243919316
Report Number1627487-2021-12941
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734401715
UDI-Public05414734401715
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/06/2020
Device Model Number3189
Device Catalogue Number3189
Device Lot Number6486505
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODE 3189 LEAD; MODE 3189 LEAD
Patient Outcome(s) Other;
Patient Age35 YR
Patient Weight77
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