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

Model Number 97714

Device Problem Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 06/01/2016

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 who was implanted with a neurostimulator for non-malignant pain. It was reported that when the patient saw the health care provider, he noted that the implantable neurostimulator appeared too close to the surface and told the patient that it "doesn't look good. " the patient has had no fall or trauma or significant weight loss. The patient stated that it is painful, and after seeing the health care provider the day prior to the report, they are checking for infection in addition to another follow-up appointment on (b)(6) 2016. This had been occurring since (b)(6) of 2016.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer on 2017-02-24 reported that the health care professional (hcp) checked the ins and it was too close to the surface of the skin of their rear end. It was exposed and ¿you can see it. ¿ the device coming to the surface occurred in (b)(6) 2015. They went to the hcp and ¿it should not be looking that way. ¿ the patient reported that their health had not been good and it might be an infection. It was reported that there was erosion at the ins. There was a potential infection as there was erosion through their skin and the ins was sticking out of their rear end. The information was not confirmed. The patient had reported the issue to their hcp and they would be meeting next week to test for infection. The patient stayed indoors and was lately feeling sick and not feeling well. The patient wanted to deal with their back. Since implant the pain was excruciating and it was a misery.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5972034
• MDR Text Key: 102483959
• Report Number: 3004209178-2016-19530
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/22/2016 Patient Sequence Number: 1