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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 Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/13/2020
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: 3006705815-2020-32348. It was reported that the patient experienced ineffective therapy. Troubleshooting revealed the lead to be partially pulled out of the header. As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the lead was explanted and replaced. Issue resolved.

 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10767343
MDR Text Key214092854
Report Number1627487-2020-33065
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 11/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/10/2020
Device MODEL Number3228
Device Catalogue Number3228
Device LOT Number6617126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2018
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: 10/31/2020 Patient Sequence Number: 1
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