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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION

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ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION Back to Search Results
Model Number 3341
Device Problem High impedance (1291)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 12/28/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. 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 reference number: 1627487-2021-00194, 1627487-2021-00195, 1627487-2021-00196, 1627487-2021-00197, 1627487-2021-00198. It was reported the patient experienced shocking sensations when the stimulation was on. Diagnostics showed multiple high impedances on the leads. As a result, surgical intervention was undertaken where in the leads and extensions were explanted and replaced resolving the issue.
 
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Brand NameEXTENSION, DUAL 4 CHANNEL 10CM
Type of DeviceSCS EXTENSION
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 Key11146694
MDR Text Key226009374
Report Number1627487-2021-00199
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
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Model Number3341
Device Catalogue Number3341
Device Lot Number5125768
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 Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2015
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: 01/11/2021 Patient Sequence Number: 1
Treatment
LEAD EXTENSION; PERCUTANEOUS LEADS (2); SCS LEAD (2)
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