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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 Fracture (1260); High impedance (1291)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided on the final report.
 
Event Description
Related manufacturer report: 1627487-2021-00317. It was reported that patient experienced ineffective stimulation. The lead had high impedance on all contacts through one to eight. Programming changes were attempted however it was unsuccessful. Upon x-ray review, lead fracture was observed. No surgical intervention is anticipated at this time. No additional information is available at this time.
 
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Brand NameOCTRODE LEAD KIT, 90CM LENGTH
Type of DevicePERCUTANEOUS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11179669
MDR Text Key227135268
Report Number1627487-2021-00318
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/05/2021
Device Model Number3189
Device Catalogue Number3189
Device Lot Number7168595
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/15/2021 Patient Sequence Number: 1
Treatment
SCS LEAD
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