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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 Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  Injury  
Manufacturer Narrative
Date of event and therapy date are estimated.
 
Event Description
Related manufacturer reference number: 1627487-2021-16450. It was reported that during an ipg replacement surgical procedure that occurred on (b)(6) 2021 (documented in manufacturer report 1627487-2021-16446), high impedances were measured on each electrode of one of the patient's leads. As a result, surgery may occur to address the issue. It is unknown which lead had the high impedances, so both applicable leads are being reported.
 
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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 Key12349348
MDR Text Key267514348
Report Number1627487-2021-16451
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 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2014
Device Model Number3189
Device Catalogue Number3189
Device Lot Number3605753
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2012
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: 08/20/2021 Patient Sequence Number: 1
Treatment
SCS LEAD
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