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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

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ABBOTT MEDICAL PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3662
Device Problem Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 07/22/2021
Event Type  Malfunction  
Event Description

It was reported that the patient's ipg stopped communicating with external devices following an ipg pocket revision (related manufacturer reference number 1627487-2021-15945) on (b)(6) 2021. Surgery mode was not enabled prior to the surgery. A manufacturer representative met with the patient and reset the ipg. Stimulation therapy was restored.

 
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Brand NamePROCLAIM 7 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 Key12290422
MDR Text Key265553501
Report Number1627487-2021-16172
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 10/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/02/2019
Device MODEL Number3662
Device Catalogue Number3662
Device LOT Number6145109
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 Received09/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/02/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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