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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193); Inadequate Pain Relief (2388); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient reported that they stopped using the stimulation because it was frustrated that when they would go to bed it would stimulate so rapidly it wouldn't stop so they stopped using it so they can go to sleep at night.Patient says they last charged and felt stimulation "about a year ago".Patient hasn't tried to connect and charge implant.Patient reported that currently, their legs are cramping and locking up.Patient reported they can feel the pain go down and lock up their legs indicating it was excruciating pain.Patient was re-directed to health care provider (hcp) to get them out of overdischarged state and to look at settings to see if it will help with pain.Patient reported programmer quit working and indicated that it wasn't connecting to implant.Patient was advised to follow up with hcp about overdischarge and can call back for troubleshooting.

Event Description

Additional information was received from the patient indicating that they never did find a physician to help her to set up a meeting to attempt to jumpstart the suspected od.The patient thought they needed their equipment replaced.Patient services (pss) reviewed that they would not send any equipment until she meets with hcp and/or rep for in person troubleshooting.Pss offered to send an hcp list again and urged caller to get a doctor to check the ins.Then if there were equipment issues she could call back for a replacement.The patient repeated information regarding the device causing cramping in her legs.

Manufacturer Narrative

Continuation of d10: product id: neu_ptm_prog, lot# serial#: unknown, product type: programmer, patient.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.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.

• 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
• MDR Report Key: 10600533
• MDR Text Key: 208996757
• Report Number: 3004209178-2020-16886
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Age: 74 YR