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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 Disconnection (1171)
Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer report numbers 3006705815-2020-33351, 1627487-2020-49090. It was reported that the patient's leads were showing all low impedances. It was found that one of the leads had disconnected from the ipg header. In turn, patient underwent surgical intervention on (b)(6) 2020 wherein the lead was reinserted into the header, resolving the issue and restoring therapy. Note: as it is unknown which lead had disconnected, both leads are being reported.

 
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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 Key11050778
MDR Text Key223056424
Report Number1627487-2020-49091
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/06/2020
Device MODEL Number3662
Device Catalogue Number3662
Device LOT Number6388764
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 Received01/29/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2018
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: 12/21/2020 Patient Sequence Number: 1
Treatment
3186, SCS LEAD (2)
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