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

Model Number 97714

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Discomfort (2330); Ambulation Difficulties (2544); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Caregiver reported that the patient's implanted neurostimulator (ins) had been turned off ahead of time for a shoulder surgery scheduled for (b)(6) 2021, but the patient was still feeling stimulation and kept getting jolted, which was bugging the patient and causing discomfort.  additionally, the caregiver reported the device made the patient fall and when they helped the patient up they could see the patient just jerk.  the exact date this began was unknown; they just stated it had been going on for "a while".   they did not have the programmer or recharger available at the time of the call, so they were going to call back on (b)(6) 2021 for further troubleshooting.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Patient reported that one day it made them fall straight on their back now their back makes weird noises and hurts more.Patient stated it has also made them have many days to use a wheel chair.Patient stated it made both shoulders hurt more; that was whenever it made them fall.Patient stated it did not cause more damage but irritated them.Patient stated not sure when it started, 2020.Patient stated they saw two doctors that checked it and stated it was off.Patient reported that after their hcp put a second stimulator in for pain, both stimulators did not work right.Patient stated the ins was off before surgery and not because they were having surgery.No actions/ interventions taken at this time.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11836275
• MDR Text Key: 267305372
• Report Number: 3004209178-2021-07820
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 73