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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.
 
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.
 
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Brand Name
PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11183219
MDR Text Key227489381
Report Number1627487-2021-00308
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020222
UDI-Public05415067020222
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2018
Device Model Number3662
Device Catalogue Number3662
Device Lot Number5564553
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2020
Initial Date FDA Received01/17/2021
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487/09/12/2017/001-C
Patient Sequence Number1
Patient Age46 YR
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