MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Dizziness (2194); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pain from the device.Pt would like to have the system taken out.Pt reported the ins had come all the way up to the skin and it hurt.Pt said it had not been doing any good, it hurt more than never.Pt noticed it probably about 6 months ago when they put a pair of pants and went to pull them up, touched the device and noticed it was right to the skin.Their friend saw it said the ins was sticking out.Asked if pt had any falls.Pt said they were in a wheelchair constantly now because of falls.Pt said they can walk but get dizzy and fall.Pt called to ask manufacturer to remove the device.Pt does not have a managing hcp.Pt has a primary care hcp who told them to contact manufacturer.Pt then became emotional and started crying.Pt said they had so many back surgeries due to this and got to the point where they could not even walk.Pt got up in the morning and the legs just phased out on them, they could not use them.It was the most painful thing they ever gone through.They came and got the pt in an ambulance-that was in texas.They told the pt with the surgery there was a 99% pt would not walk.Pt got lucky and could walk.But pt has to take pain medicine every day.Asked if surgeries were related.Pt said some surgeries were related.Asked for event date.Pt said "issues been every year".They had to go in and repair discs.They could not patch the spine because that area was wrapped and wrapped with wires.The wires were wrapped around the sciatic nerve.They could not do anything.It hurt.Pt said they started to get bumps all the way up their spine.There was so much damage that no hcp wants to touch it.It is wrapped around their sciatic nerve.It built scars, caused 7 back surgeries, caused falls and pt broke their face.Pt said they had to take morphine every day."that thing bends, right there by the skin, there are horrifying knots as you go up".In the past every time pt had a problem pt had to schedule an appointment with manufacturer: the battery went dead twice, then they met because they wanted to put a system where the batteries were on the outside, then pt had 7 back surgeries, then it started causing pt to fall and break their face, then ins moved up all the way to the skin.Pt said they could not wear certain clothes.Additional information received from the healthcare provider (hcp) reported that they had last seen the patient for an x-ray on (b)(6) 2016.The patient had been concerned that a fall had affected the leads, but the x-ray showed the leads were still in the correct place.It was noted that the patient did not have 7 surgeries in their file, the only reference the hcp had of surgery was for a back surgery between 2012 and 2013.The hcp also noted the patient was not a good historian and had psycho-social issues unrelated to the device/therapy.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12602052
• MDR Text Key: 276634748
• Report Number: 3004209178-2021-15119
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/09/2021
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention