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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Seroma (2069); Implant Pain (4561)
Event Date 12/30/2020
Event Type  Injury  
Manufacturer Narrative
Date of event¿ is estimated. A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event. Based on the information provided a device problem was not identified. As a result, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
Event Description
It was reported that patient had seroma and infection at lumbar ipg site. The patient also felt the ipg when sleeping. The patient was prescribed oral antibiotics and the seroma resolved. Afterwards, due to possible infection, surgery occurred during which the ipg was explanted, ipg pocket was washed out with antibiotics, and smaller ipg was implanted. The issues have resolved.
 
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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 Key11359165
MDR Text Key232857651
Report Number1627487-2021-01060
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
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/30/2020
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6477992
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 Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/22/2021 Patient Sequence Number: 1
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