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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 Premature Elective Replacement Indicator (1483)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017. The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the elective replacement indicator (eri) triggered earlier than intended. The wireless software update was performed clearing the eri message. The device is providing therapy.
 
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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 Key11183219
MDR Text Key227489381
Report Number1627487-2021-00308
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2018
Device Model Number3662
Device Catalogue Number3662
Device Lot Number5564553
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 Received01/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/09/12/2017/001-C

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