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); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Chest Pain (1776); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Complaint, Ill-Defined (2331)

Event Date 01/12/2018

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 patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient was having severe chest pain ;like having a stick on the left side of her chest.The patient thought that the pain was a pulled muscle because she had muscle spasms all the time, but it was confirmed by an orthopedic doctor that the pain was not a pulled muscle.It was also reported that on the saturday prior to the report when she was driving, a vibrating sensation was felt in her left arm/side and when she turned off the car, she would still feel the ¿buzzing¿.It was a sensation that the patient usually felt in her back and legs from the device.The patient said she turned her stimulation off and the ¿buzzing¿ in her upper left side continued then stopped.Typically, when she turns the stim off, she continues to feel stim for a while.When asked if any falls were related to the issues, the patient stated that she had a couple of falls in the previous summer.Lastly, when the patient turned the device back on, she immediately started to feel stimulation in her upper left side.The patient was redirected o their healthcare professional (hcp) and a manufacturer representative (rep) to have the device checked and possibly reprogrammed.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They did not know for sure what could have caused the buzzing to be felt in their left arm/side; they noted maybe it was due to falling three times in the previous fall season, and they did not know if the falls had affected their implanted system.They also did not know why they were continuing to feel the buzzing after turning off their device.They ended up seeing a cardiologist for the chest pain, and had x-rays to check the leads.The results of the x-rays have not yet been received.They also met with a manufacturer representative (rep) who tried reprogramming.The buzzing issues, chest pain and muscle spasms have not totally resolved; they reported they were still working this through.

• 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: 7340665
• MDR Text Key: 102453820
• Report Number: 3004209178-2018-05051
• 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: 04/24/2018

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: 05/14/2016
• 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: 03/12/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 04/24/2018
• Date Device Manufactured: 06/24/2015
• 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 Age: 72 YR
• Patient Weight: 73