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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 Failure of Implant (1924)
Event Date 06/18/2021
Event Type  Injury  
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.Date of event is estimated.
 
Event Description
It was reported 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
A false elective replacement indicator message was reported to abbott but could not be confirmed.The results of the investigation are inconclusive since the device nor logs or records were returned for analysis.Actions have been taken to prevent reoccurrence.
 
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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 Key12184024
MDR Text Key262051323
Report Number1627487-2021-15701
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,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2019
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6147501
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487/09/12/2017/001-C
Patient Sequence Number1
Patient Weight69
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