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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 Problems Disconnection (1171); High impedance (1291)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative

¿date of event¿ is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference numbers: 3006705815-2020-31025. 3006705815-2020-31026. It was reported that the patient fell and experienced ineffective therapy. Diagnostic testing revealed high impedance on multiple contacts of one lead. Imaging showed that the lead migrated. Additional information was received that the right-side lead had slightly migrated and the left-side lead had slightly come out of the ipg header. Surgery occurred on (b)(6) 2020 during which the left-side lead was reinserted into the ipg header to address the issue. It is unknown which lead is the right-side lead and which lead is the left-side lead.

 
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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
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10633178
MDR Text Key209952801
Report Number1627487-2020-32047
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/27/2019
Device MODEL Number3662
Device Catalogue Number3662
Device LOT Number5958572
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 Received11/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/27/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 10/06/2020 Patient Sequence Number: 1
Treatment
PERCUTANEOUS LEAD (X2)
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