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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 02/04/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 977a160, serial# (b)(4), product type lead.Product id 977a260, serial# (b)(4), product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the ins is not acting right.Patient inquired to meet with manufacturing representative (rep) at patient's visit next week on (b)(6) at 10:15 in health care professional (hcp) office.Patient further clarified indicating that all of a sudden the ins was not giving patient relief.Patient said they have not had any fall or anything and patient has not been doing any heavy lifting.Patient believed the ins needs to be "recalibrated".Patient said recently they suspect a slight migration of patient leads.Patient said patient does not know if that is the issue, but patient's adaptive stim would not recognize the correct position.Patient said when patient is laying down patient programmer shows standing.Patient said with his high density settings patient is not supposed to feel stimulation, but patient is feeling stimulation.Patient indicated they emailed rep about the issue on (b)(6) 2018.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a160, (b)(4) implanted: explanted: product type lead.Product id: 977a260, (b)(4) implanted: explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative.It was reported that the patient was getting 50% pain relief and was happy with the stimulation.The patient reported that at times they still felt strong stimulation when not expected, but this could be positional.The patient canceled the appointment with the representative to adjust the device.The remote screen needed to be refreshed for adaptive stim to show the position changes.The patient said the stimulation was changing appropriately with position changes.The representative reported that the issue had been resolved.This information was confirmed with the physician/account.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: 7286277
• MDR Text Key: 100778193
• Report Number: 3004209178-2018-03700
• 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
• Report Date: 04/25/2018

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: 12/28/2017
• 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: 02/14/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 04/25/2018
• Date Device Manufactured: 02/07/2017
• 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 Age: 47 YR
• Patient Weight: 104