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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 Wireless Communication Problem (3283)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event is estimated. Reporter phone number: (b)(6).
 
Event Description
It was reported the patient had an abdominal surgery where the device was not placed in surgery mode. Subsequently, the patient has been unable to connect to the ipg. Surgical intervention took place wherein the ipg was explanted and replaced to resolve the issue.
 
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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 Key12219660
MDR Text Key263213099
Report Number1627487-2021-15691
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2019
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6099497
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 Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient Treatment Data
Date Received: 07/23/2021 Patient Sequence Number: 1
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