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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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ABBOTT MEDICAL PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 01/04/2021
Event Type  Injury  
Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

 
Event Description

Related manufacturer reference number: 3006705815-2021-00090. It was reported the patients lpg to lead connection was no longer tight resulting in fluid intrusion in the ipg header. Surgical intervention was undertaken wherein the ipg and lead were explanted and replaced. Surgical intervention addressed the issue.

 
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Brand NamePROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of DeviceSCS IPG
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 Key11156860
MDR Text Key226532509
Report Number1627487-2021-00251
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3660
Device Catalogue Number3660
Device LOT Number7613115
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/10/2020
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: 01/12/2021 Patient Sequence Number: 1
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