MAUDE Adverse Event Report: ST JUDE MEDICAL, ABBOTT MEDICAL PROCLAIM DRG; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number	3875
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Was in more pain than usually and after a follow up with a st.Jude¿s representative, he told me that one lead is broken.Soon after that, i noticed, the battery inside my body is less than halfway, which i don¿t think it¿s normal.Unfortunately, my pain management doctor has abandoned me, nobody wants to do anything.Looking for a new pain management doctor now.And neither the representatives from st jude¿s are helpful, no report about this accident nor any other kind of showing interest about helping me out.

• Brand Name: PROCLAIM DRG
• Common Device Name: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ST JUDE MEDICAL, ABBOTT MEDICAL
• MDR Report Key: 8142389
• Report Number: MW5081946
• Device Sequence Number: 10836811
• Product Code: PMP
• UDI-Device Identifier: 05415067027313
• UDI-Public: (01)05415067027313(11)170628(10)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 3875
• Device Catalogue Number: 7884
• Device Lot Number: 6030787
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 48 YR
• Patient Weight: 70