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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION
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ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION Back to Search Results
Model Number 3346
Device Problem Therapy Delivered to Incorrect Body Area (1508)
Patient Problem Undesired Nerve Stimulation (1980)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.
 
Event Description
Related manufacturer reference number: 1627487-2021-12635.It was reported the patient experienced a tingling sensation at the extension header.Surgical intervention took place wherein the extensions were explanted and replaced.Tingling sensation has resolved.
 
Manufacturer Narrative
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.
 
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Brand Name
EXTENSION, DUAL 4 CHANNEL 60CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11570111
MDR Text Key242272096
Report Number1627487-2021-12634
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402309
UDI-Public05414734402309
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/28/2013
Device Model Number3346
Device Catalogue Number3346
Device Lot Number3463355
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received03/25/2021
Supplement Dates Manufacturer Received07/01/2021
Supplement Dates FDA Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL 3346 EXTENSION; MODEL 3346 EXTENSION
Patient Outcome(s) Other;
Patient Age30 YR
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