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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

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ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problems Fracture (1260); Therapeutic or Diagnostic Output Failure (3023); Migration (4003)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/02/2021
Event Type  Injury  
Manufacturer Narrative
Date of the event is estimated.
 
Event Description
It was reported the patient's lead was fractured and had slightly migrated causing ineffective therapy.Surgical intervention took place in which the lead was 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
PENTA 3MM LEAD, 60 CM
Type of Device
SCS PADDLE LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key12318067
MDR Text Key266379764
Report Number1627487-2021-16289
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734406246
UDI-Public05414734406246
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2017
Device Model Number3228
Device Catalogue Number3228
Device Lot Number5155389
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/30/2021
Initial Date FDA Received08/13/2021
Supplement Dates Manufacturer Received08/24/2021
Supplement Dates FDA Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight98
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