MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTABLE

Model Number 3058

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Pain (1994); Dizziness (2194); Shaking/Tremors (2515); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 12/12/2009

Event Type  No Answer Provided  

Event Description

Have a "bold" in my back for nothing.(b)(6), i cannot sleep well.The side where i have the implant causes me pain and severely bothers, sometimes fever, tremor, and strong dizziness.

• Brand Name: MEDTRONIC NEUROMODULATION
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 8509380
• MDR Text Key: 142188983
• Report Number: MW5085821
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: 3058
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 66