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

Model Number 97714

Device Problems Labelling, Instructions for Use or Training Problem (1318); Migration or Expulsion of Device (1395); Unintended Collision (1429); Device Difficult to Program or Calibrate (1496); Device Displays Incorrect Message (2591)

Patient Problems Pain (1994); Anxiety (2328)

Event Date 06/23/2017

Event Type  malfunction  

Event Description

Information was received from a consumer about a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that mri compatibility guidelines were requested as the patient needed an mri, which was reported to be related to the patient¿s device or therapy.It was reported that the patient had fallen and broke three ribs, their ins moved and they were having pain at their ribs.It was reported that these events occurred all on (b)(6) 2017.The patient stated that they were not sure if they dislodged the leads due to their fall.It was stated that the patient met with their healthcare provider (hcp) and manufacturing representative yesterday ((b)(6) 2017), and their hcp wanted to do an mri, but the patient did not think that they were eligible to get an mri, and the rep told them that they were and to call patient services.Patient services attempted to help the patient use their patient programmer (pp) to put their device into mri mode, but the caller stated that the pp showed the ¿charge ins¿ screen.It was reported that the patient was not able to navigate past this screen.The patient stated that they had not charged in a while because they feared of getting shocked or injured.The patient was advised to charge their ins and then get back to them to find out their mri eligibility.On (b)(6) 2017, the patient called back to see if they could get an mri done.The patient charged their device enough to be able to put it in to mri mode.Patient services walked the patient through mri mode and their device showed full body.The patient stated that they were just calling for future reference for if they would need an mri, because they said that they had been told in the past that they couldn¿t have an mri.Mri guidelines were reviewed and it was suggested that the mri technician call in to get guidelines if they were to have an mri.No further complications were reported/anticipated.

• 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: 6724031
• MDR Text Key: 80439644
• Report Number: 3004209178-2017-15094
• 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
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• Date Device Manufactured: 04/08/2014
• 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: 66 YR