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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 Problem Fracture (1260)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative

Event date is estimated.

 
Event Description

It was reported the patient experienced ineffective stimulation and x-rays indicated the lead was fractured. The patient reported having a recent fall. Surgical intervention is planned to address the issue.

 
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Brand NamePENTA 3MM LEAD, 60 CM
Type of DeviceSCS PADDLE 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 Key12364882
MDR Text Key268042013
Report Number1627487-2021-16523
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/17/2020
Device MODEL Number3228
Device Catalogue Number3228
Device LOT Number6531744
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 Received09/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/18/2018
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: 08/25/2021 Patient Sequence Number: 1
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