MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37712

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Battery Problem (2885); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 06/30/2021

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 an implantable neurostimulator (ins) for chronic low back pain, and failed back surgery syndrome.The reason for call was patient (pt) stated that her ins kicked back on a couple of weeks ago and the stimulation sensation has been getting stronger - pt stated she is feeling constant stimulation from the waist down.The pt stated it hurts in her head and down the back of her neck.She described a "stabbing pain" in her left hip down to her feet.Patient services (pss) asked if pt has had any traumas or falls recently.The pt stated no trauma but it seems like when they got "the 5g network" installed in their area - pt stated it feels like the ins kicked on after that event.The pt stated she lost the hand held programmer.The pt does not have an hcp anymore.The pt was asking if a local rep could check the ins.  the patient was redirected to their healthcare provider to further address the issue and an email was sent to the local field reps regarding pt call.

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.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

Additional information was received from the manufacturer representative (rep).It was reported that after meeting with the patient and asking questions, the patient stated that her battery has been dead for several years.The rep did attempt to connect to battery but was unable to connect due to dead battery.So as to the cause of her ¿stimulation¿ feelings, the rep has no idea.But after our meeting they would confidently say it is not coming from her scs system.The actions that were taken was the many attempts to connect to her battery with no luck.Her tingling or ¿stimulation¿ feeling was still there at the time of the meeting and patient stated that she will follow up with her primary care physician.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12229322
• MDR Text Key: 263577751
• Report Number: 3004209178-2021-11422
• 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
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2008
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR