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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 Problem Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated.

 
Event Description

It was reported that the patient's ipg stopped communicating with external devices following an unrelated surgery. A manufacturer rep met with the patient and attempted to troubleshoot, but the ipg was deemed inoperable. As a result, surgical intervention may take place at a later date to address 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 Key12238521
MDR Text Key263828490
Report Number1627487-2021-15951
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 08/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/20/2019
Device MODEL Number3660
Device Catalogue Number3660
Device LOT Number5948934
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 Received08/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2017
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: 07/28/2021 Patient Sequence Number: 1
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