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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION
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ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION Back to Search Results
Model Number 3383
Device Problem High impedance (1291)
Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.Further information requested, but not yet received.
 
Event Description
It was reported that one lead has high impedances.As a result, surgical intervention may be undertaken in the future.
 
Manufacturer Narrative
Correction: the device information has been updated to reflect the device associated with the issue.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
Additional information indicates surgical intervention was undertaken on (b)(6) 2021 wherein the extension was explanted and replaced.Issue resolved.
 
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Brand Name
EXTENSION, 30CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12104698
MDR Text Key259596815
Report Number1627487-2021-15256
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
PMA/PMN Number
K960728
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2016
Device Model Number3383
Device Lot Number4563164
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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