• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG Back to Search Results
Model Number 3660
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/10/2021
Event Type  Injury  
Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017. During processing of this complaint, attempts were made to obtain complete event information.
 
Event Description
It was reported the patient underwent a non-related surgical procedure on (b)(6) 2021 wherein the ipg was not placed into surgery mode prior to the procedure. As a result, the patient's ipg was unable to communicate with external devices and the patient lost therapy. A manufacturer representative confirmed the issue and the ipg was deemed inoperable. Surgical intervention may be pending to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12940916
MDR Text Key281840577
Report Number3006705815-2021-06005
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 Health Professional,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000103858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2020
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: 12/06/2021 Patient Sequence Number: 1
Treatment
SCS ANCHOR (X2); SCS LEAD (X2)
-
-