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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 Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The patient's weight was unable to be obtained. 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

Device 1 of 3. Reference mfr. Report#: 1627487-2020-49195. Reference mfr. Report#: 3006705815-2020-33398. It was reported the patient was unable to set their ipg into mri mode due to a combination of high and low impedance related to one of the patient's leads. As a result, the patient underwent surgical intervention on (b)(6) 2020. During the procedure, the lead related to the impedance issue was found to be disconnected from the ipg header. In turn, the doctor reconnected the lead to the ipg header. Surgical intervention addressed the patient's issue. Note: both of the patient's leads are being reported because it's unknown which lead was liable.

 
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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 Key11067480
MDR Text Key223471919
Report Number1627487-2020-49194
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/21/2010
Device MODEL Number3186
Device Catalogue Number3186
Device LOT Number119461
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 Received11/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2008
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: 12/23/2020 Patient Sequence Number: 1
Treatment
MODEL: 3186; MODEL: 3662
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