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

MAUDE Adverse Event Report: PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M 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
 

PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M SCS IPG Back to Search Results
Model Number 3661
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. 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.
 
Event Description
It was reported that the patient underwent an unrelated surgical procedure. Patient did set the ipg into surgery mode as recommended. Thereafter, the ipg failed to establish communication with external device. Recovery efforts were unsuccessful and the ipg was deemed inoperable. Patient is not receiving therapy and may require surgical intervention to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M
Type of DeviceSCS IPG
MDR Report Key12591019
MDR Text Key275196931
Report Number1627487-2021-17445
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/27/2020
Device Model Number3661
Device Catalogue Number3661
Device Lot Number7117814
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
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: 10/07/2021 Patient Sequence Number: 1
-
-