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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)

Patient Problems Erosion (1750); Erythema (1840); Hematoma (1884); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that there was unexpected stimulation.The patient mentioned there was interference from a commercial microwave.The patient showed some dark colored spots on the right arm, like hematomas, that were fading since the event.The ins was said to be working normal.The rep reprogrammed the ins and that is when the patient mentioned the incident.Impedance tests were normal and service life showed ok during device interrogation.Pain coverage in the right arm was achieved.The patient appeared to be well, with good health and no physical challenges.The patient was dismissed from the hcp appointment without any remarks about the incident.No further steps were required as the device was working normally.The patient was advised to keep a distance of more than 3 feet from the source of interference and to discuss any possible accommodations with the employer.The issue was said to be resolved.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a representative (rep) regarding the patient.It was reported that the patient was not a trial patient.No further complications were reported.Follow up was conducted.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported via the manufacturer representative that they work in a restaurant and were in front of an industrial microwave oven when the device gave her overstimulation in the right arm.An hour after the overstimulation the arm had a lot of hematoma.The patient went to their family doctor who prescribed toradol and rest.The issue was not resolved at the time of the report.The patient had a burning sensation, erosion, pain and redness at the right arm.Additional information received from the manufacturer representative reported that the device was interrogated and everything was normal with the battery, impedances and programs.It was unknown what the erosion was related to.The issue of overstimulation and interference had not occurred again as the patient had not stopped in front of the microwave oven again.

• 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 MN 00777 1200
• MDR Report Key: 7386348
• MDR Text Key: 104134920
• Report Number: 3007566237-2018-00935
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

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: 05/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 03/07/2019
• Supplement Dates FDA Received: 05/06/2018; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 49