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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 30CM SCS EXTENSION

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ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 30CM SCS EXTENSION Back to Search Results
Model Number 3343
Device Problem Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/01/2021
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. During processing of this incident, attempts were made to obtain complete event information.

 
Event Description

Related manufacturer reference number: 1627487-2021-16694. Related manufacturer reference number: 1627487-2021-16695. Related manufacturer reference number: 1627487-2021-16698. It was reported patient had loss of therapy due to the ineffective coverage of dual occipital and dual supra orbital system. Images indicated that the dual extension were kinked and fractured. As a result, surgical intervention took place wherein the ipg and one extension was explanted and replaced with new ones. Post operatively effective stimulation was restored. It is unknown which extensions addressed the issue and therefore all extensions are being reported.

 
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Brand NameEXTENSION, DUAL 4 CHANNEL 30CM
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 Key12393095
MDR Text Key268976020
Report Number1627487-2021-16696
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,Followup
Report Date 09/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2015
Device MODEL Number3343
Device Catalogue Number3343
Device LOT Number4214713
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 Received09/09/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2013
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: 08/31/2021 Patient Sequence Number: 1
Treatment
MODEL 3343; MODEL 3383; MODEL 3789
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