• 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 QUATTRODE LEAD WIDE SPACED, 60 CM PERCUTANEOUS LEAD

  • 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 QUATTRODE LEAD WIDE SPACED, 60 CM PERCUTANEOUS LEAD Back to Search Results
Model Number 3166
Device Problem Fracture (1260)
Patient Problem Undesired Nerve Stimulation (1980)
Event Date 06/22/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. 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
Related manufacturer reference number: 1627487-2021-16829. It was reported that the patient experienced ineffective and uncomfortable stimulation. Diagnostics revealed high impedances on all contacts of one lead. As a result, surgical intervention was undertaken wherein the lead was explanted and replaced. During the procedure, it was discovered that the lead had a fracture. Post-operatively, stimulation therapy was restored. It is unknown which lead had fractured and was replaced, therefore both leads are being reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUATTRODE LEAD WIDE SPACED, 60 CM
Type of DevicePERCUTANEOUS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12433756
MDR Text Key270123236
Report Number1627487-2021-16830
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3166
Device Catalogue Number3166
Device Lot Number7629577
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 Received08/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
Treatment
PERCUTANEOUS LEAD
-
-