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 PENTA 3MM LEAD, 60 CM; SCS PADDLE 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 PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Event Description
It was reported the patient's thoracic penta lead was cut and explanted during an elective ipg replacement on (b)(6) 2020.
 
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
PENTA 3MM LEAD, 60 CM
Type of Device
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11162530
MDR Text Key226539180
Report Number1627487-2021-00262
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734401913
UDI-Public05414734401913
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 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2014
Device Model Number3228
Device Catalogue Number3228
Device Lot Number3619284
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight102
-
-