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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 High impedance (1291)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-49230, 1627487-2020-49231.It was reported the patient underwent surgical intervention on (b)(6) 2020 to address an inoperable ipg issue.(reference reg report: 3006705815-2020-30556) during the procedure, diagnostics showed high impedance on multiple contacts.In turn, the patient's leads and extensions were explanted and replaced to address the issue.
 
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 Key11076254
MDR Text Key223717655
Report Number1627487-2020-49229
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,health
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2014
Device Model Number3346
Device Catalogue Number3346
Device Lot Number3590765
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD X2; SCS LEAD X2
Patient Outcome(s) Other;
Patient Weight105
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