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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD

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ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3186
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
Related manufacturer report number: 1627487-2021-00181; related manufacturer report number: 1627487-2021-00182. It was reported that the patient had the scs system explanted due to unknown reason.
 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DeviceSCS 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 Key11136297
MDR Text Key225721480
Report Number1627487-2021-00183
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
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/17/2018
Device Model Number3186
Device Catalogue Number3186
Device Lot Number5508962
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 Received01/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
Treatment
MODEL 3186, SCS LEAD; MODEL 3771, SCS IPG
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