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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD

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ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD Back to Search Results
Model Number 3189
Device Problems Fracture (1260); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/27/2021
Event Type  malfunction  
Manufacturer Narrative
Event date is an estimate. 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.
 
Event Description
Related manufacturer report number: 1627487-2021-16271. It was reported the patient experienced ineffective therapy. Diagnostics indicated that the leads had multiple contacts with high impedance. It was noted that the leads seemed to be fractured.
 
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Brand NameOCTRODE LEAD KIT, 90CM 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 Key12315237
MDR Text Key266281322
Report Number1627487-2021-16270
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 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number3189
Device Catalogue Number3189
Device Lot Number7045438
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 Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
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: 08/12/2021 Patient Sequence Number: 1
Treatment
SCS LEAD, MODEL 3189
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