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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); Impedance Problem (2950)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/12/2021
Event Type  Injury  
Manufacturer Narrative
Date of the event is estimated.
 
Event Description
Related manufacturer reference number: 1627487-2021-16586. It was reported the patient's system was auto-reducing due to invalid impedances on both leads. Surgical intervention took place in which the leads were explanted and replaced to address the issue. Therapy was restored.
 
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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 Key12367015
MDR Text Key268117850
Report Number1627487-2021-16585
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3189
Device Catalogue Number3189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
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: 08/25/2021 Patient Sequence Number: 1
Treatment
MODEL # 3189 - LEAD
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