MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC STIMULATION SYSTEM IMPLANT; STIMULATOR, ELECTRICAL, IMPLANTABLE

Model Number 3058

Device Problems Break (1069); Moisture Damage (1405)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Leads broken, stimulator was removed on (b)(6) 2016, had condensation in battery.Put all new battery and leads, never worked.Medtronic did test.I could not have unit tested by a lab that had nothing to gain or loose.Device has caused severe pain on left side and down left leg, up my spine where leads were inserted first time - second unit.This was the worse mistake in my life.Second opinion said i must get removed as soon as possible.He said i will still have pain due to 3 surgeries in the same area.Nerves damage and cut in my second surgery was deeper.Medtronic said it ((b)(6) 2016) worked correctly and did not see damage.Dr (b)(6) and (b)(6), sale rep for medtronic told me after second surgery that was their finding.I did not authorize to have 2nd unit put in, i went to surgery for leads only.My pain never goes away.

• Brand Name: MEDTRONIC STIMULATION SYSTEM IMPLANT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6732309
• MDR Text Key: 80785270
• Report Number: MW5071129
• Device Sequence Number: 1
• Product Code: NHL
• 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: 06/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 77