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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 Problems High impedance (1291); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-32126.It was reported that, during implant surgery on (b)(6) 2020, a contact was sheared from the lead and there was high impedance on 1 contact of the lead.The lead was left implanted in patient.It is unknown from which lead the contact sheared, so both leads are being reported.The sheared contact is reported in manufacturer reference numbers 1627487-2020-32123 and 1627487-2020-32124.
 
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 Key10646821
MDR Text Key210373390
Report Number1627487-2020-32125
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,health
Type of Report Initial,Followup
Report Date 12/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2022
Device Model Number3189
Device Catalogue Number3189
Device Lot Number7575918
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PERCUTANEOUS LEAD; PERCUTANEOUS LEAD
Patient Weight113
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