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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Connection Problem (2900); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that when the patient was implanted with the current ins, there was a problem hooking the old cable up to the new one (new ins).The patient reported she currently had a problem with the ins.The patient explained that she had problems with pain because when she was sitting down or lying down, the stimulation "knocked the signal down from what it previously was".Patient stated that the ins did not turn off but the stimulation decreased from what it was previously set at.The patient stated that she had been dealing with this issue for quite some time, noting it had been 2-3 years.Patient stated she had previously met with reps who did troubleshooting in person to confirm the ins was not turning off.Additional information was received from the rep who reported they were notified on november 11th.It was reported the patient was in an accident in 2016.All impedances were checked and within normal limits.Adaptive stim was off.Encouraged patient to try other groups that the rep programmed last.Also, suggested she find a pain provider who could possibly get an x-ray to check lead placement.No further complications were reported/anticipated.

Event Description

Additional information was received from the patient on 2020-mar-02.It was reported that the patient had pain that went down to her feet and the feet were numb ¿like bands were toes¿.The patient stated that the pain was down back across the hips and down the legs.It was also reported that the patient set her implantable neurostimulator (ins) to high settings to tolerate the pain and for some reason, it acted like there was a short in it.The stimulation would run, and it would hit the patient ¿like a short in a light¿.The patient stated that the manufacturer representative (rep)s checked the device and found nothing wrong.A rep told the patient to turn off the ins and, in the end, the patient was getting a lot programming done and she ended up losing power.There were no further complications reported or 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: 9459582
• MDR Text Key: 175251601
• Report Number: 3004209178-2019-23694
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Date Device Manufactured: 09/26/2015
• 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 Weight: 84