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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544)

Event Date 03/17/2018

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.It was reported that their device worked fine up until (b)(6) 2018.The patient stated that they were in horrendous pain, wouldn't walk, and their feet didn't want to move.The patient was taken to the er, then to the hospital, and then to a rehabilitation facility.This was considered to be a sudden change in therapy/symptoms.It was noted that the patient wanted to meet with a manufacturer representative for reprogramming.The patient was redirected to follow up with their healthcare provider (hcp) to contact the manufacturer representative.No further complications were reported or anticipated.Indications for use are spinal pain and lumbar radiculopathy.

Manufacturer Narrative

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

Event Description

It was noted that the patient was hospitalized for observation after being at the er.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer.It was reported that on (b)(6) 2018 they experienced an increase in pain in their left hip and down their left leg.It worsened to the point where they went to see their doctor the same day.An x-ray showed merely arthritis.They started a steroid pack.They had been doing some lifting weeks prior before but the pain was much more intense.By the end of the day it was painful to walk on their left leg so they took their evening medication and went to bed.They woke up and it was very painful and they needed help getting out of the bed.It was uncomfortable to sit.They were in tears from the pain.They didn't try to change their stimulator to help the left side pain as previous attempts to achieve stimulation there had been unsuccessful.Eventually they were able to stand up with help from their husband.Their legs didn't seem to want to move and were in pain- they felt tingly and numb.Any movement caused extreme pain.They noted that the pain was sudden.They had been working at their father's home and helped moving boxes of household items.The noted they used their legs rather than their back and had been doing that for almost a year with success.They decided to go to the er but they couldn't walk down the stairs so the called an ems.They were given medication through an iv but it didn't help much.They tried exercises and took their usual medication and made sure they had a fresh battery on their controller and increased the stimulation.That's all they knew to try.The neurostimulator didn't cover their left side- they learned this after it was first installed and increasing it on the right side didn't help.They were given injections at the er for pain and couldn't tell if there was any change for the better as a result.They noted that tylenol 4 and home pt visits seemed to help them a lot.They increased their walking time to about 13 minutes before their hip and leg start to really hurt.They burn from under their buttock down their left leg to right above their ankle.The patient still had back pain but it was more manageable.They can't walk longer distances now as the pain in their left hip, back and leg was more than before (b)(6).They still experienced tingling, numbness, and sometimes stinging on their left big toe and a burning sensation on their left leg all the way to their ankle.Their right big toe was numb most of the time.They developed incontinence and noted that it was impossible to keep from wetting their self.Ultimately they wished their neurostimulator placement gave them more coverage on their left side.They met with a representative to provide left side coverage but the efforts were unsuccessful.They weighed (b)(6) at the time of the event on (b)(6) 2016.No further complications reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7413737
• MDR Text Key: 104927129
• Report Number: 3004209178-2018-06953
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 05/01/2018; 05/01/2018
• Supplement Dates FDA Received: 05/18/2018; 05/18/2018
• Date Device Manufactured: 07/22/2016
• 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): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 90