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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 Disconnection (1171); Failure to Deliver Energy (1211)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference number: 1627487-2020-49368, 1627487-2020-49369. It was reported the patient experienced a loss of stimulation due to the extensions not being locked down. Surgical intervention took place wherein the extensions were explanted and replaced. Effective therapy was restored.

 
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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 Key11096325
MDR Text Key224412857
Report Number1627487-2020-49367
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2016
Device MODEL Number3228
Device Catalogue Number3228
Device LOT Number4879537
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 Received01/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/15/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 12/30/2020 Patient Sequence Number: 1
Treatment
MODEL 3383 X 2 EXTENSION
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