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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 60CM SCS EXTENSION

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ABBOTT MEDICAL EXTENSION, 60CM SCS EXTENSION Back to Search Results
Model Number 3386
Device Problems Disconnection (1171); Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

It was reported the patient was unable to feel stimulation. Diagnostics indicated high impedance readings. Surgery was undertaken and the extension was found to be almost completely out of the implantable pulse generator (ipg) header. Intra-operative diagnostics of the lead showed no anomalies, however high impedance readings were noted when testing the extension. The extension was explanted and replaced. No intervention was taken with respect to the lead or ipg. Replacing the extension resolved the issue.

 
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Brand NameEXTENSION, 60CM
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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10848710
MDR Text Key216627704
Report Number1627487-2020-47873
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/06/2020
Device MODEL Number3386
Device Catalogue Number3386
Device LOT Number6617129
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/16/2020 Patient Sequence Number: 1
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