Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION Back to Search Results
Model Number 3383
Device Problems Disconnection (1171); Failure to Deliver Energy (1211)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
Date of 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: 1627487-2020-49367, 1627487-2020-49369.It was reported the patient experienced a loss of stimulation due to the extensions not being locked down.Surgical intervention took place wherein the extensions were explanted and replaced.Effective therapy was restored.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXTENSION, 30CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11096297
MDR Text Key224410997
Report Number1627487-2020-49368
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402323
UDI-Public05414734402323
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 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/20/2021
Device Model Number3383
Device Catalogue Number3383
Device Lot Number7115811
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL 3228 LEAD; MODEL 3383 EXTENSION; MODEL 3228 LEAD; MODEL 3383 EXTENSION
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight82
-
-