MAUDE Adverse Event Report: MEDTRONIC INC RESTORE SENSOR NEUROSTIMULATOR; STIMULATOR, SPINAL CORD, IMPLANTED FOR PAIN

Model Number 97714

Device Problems Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problems Headache (1880); Pain (1994); Foreign Body In Patient (2687)

Event Date 12/04/2018

Event Type  Injury  

Event Description

Reporter alleges she had implant to relieve her of migraines.After the implant, she felt a bump and reported to the nurse who took a look and said it was a pimple.Five days after the implant one of the leads had migrated and was protruding on the back of her scalp.Reporter says she went to the doctor the next day and he manually pushed the lead back and stapled the open scalp and advised it was ok to wash her hair the next day.Reporter alleges she washed her hair and felt the wire/lead out of her scalp.She called the physician to report and got a call back for scheduled surgery on (b)(6) 2018.One of the lead/wire was removed during surgery.The device functions but report has not been able to use it due to the pain she experiences when she tries to use it.She feels the pain from her scalp and it radiates to her neck, shoulder and upper back of her right side.This has limited her mobility and performing other activities.Reporter thinks medtronic should let consumers know the device is not appropriate for people with thin scalp and elderly.She has an appointment on (b)(6) 2019 to discuss explant of the device.

• Brand Name: RESTORE SENSOR NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL CORD, IMPLANTED FOR PAIN
• Manufacturer (Section D): MEDTRONIC INC
• MDR Report Key: 8222081
• MDR Text Key: 132415475
• Report Number: MW5082856
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 97714
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 57