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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 Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative

Date of the event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference number: 1627487-2020-33468, 1627487-2020-33469, 1627487-2020-33470. It was reported the patients right occipital lead pulled out of the extension and was damaged. Surgical intervention took place wherein the lead and extension was replaced to address the issue. Therapy was restored post-op. Note: it is unknown which lead pulled out and was damaged, as such both leads and extensions are being reported.

 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10809058
MDR Text Key215283719
Report Number1627487-2020-33471
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3341
Device Catalogue Number3341
Device LOT Number7564659
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 Received12/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2020
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: 11/09/2020 Patient Sequence Number: 1
Treatment
MODEL # 3240 - LEAD (X2); MODEL # 3341 - EXTENSION
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