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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/19/2020
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
Manufacturer report reference number: 1627487-2020-48501, 1627487-2020-48502. It was reported that while the patient was undergoing a surgical intervention due to shocking at the ipg site (manufacturer report reference number: 1627487-2020-48503, 1627487-2020-48504) and lead migration (manufacturer report reference number: 1627487-2020-47815, 3006705815-2020-32723, 1627487-2020-47816, 3006705815-2020-32724), the patient began bleeding profusely. The patient had been off anticoagulant for approximately 48 hours but the surgeon did not feel it was long enough due to the amount of bleeding. The bleeding did cease post operatively.
 
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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 Key10938330
MDR Text Key219307315
Report Number1627487-2020-48500
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/22/2020
Device Model Number3189
Device Catalogue Number3189
Device Lot Number6445071
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 Received12/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2018
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: 12/03/2020 Patient Sequence Number: 1
Treatment
MODEL 3189, SCS LEAD; MODEL 3662, SCS IPG
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