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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
Event Date 10/12/2021
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Date of event is estimated.
 
Event Description
It was reported that the patient's ipg was inoperable.As a result, the physician explanted and replaced the ipg.Surgical intervention resolved the issue.
 
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Brand Name
PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS 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 Key12725703
MDR Text Key279252435
Report Number1627487-2021-18026
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020192
UDI-Public05415067020192
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 Physician
Type of Report Initial
Report Date 10/31/2021
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/19/2018
Device Model Number3660
Device Catalogue Number3660
Device Lot Number5606907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received10/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2016
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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