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

Model Number 37712

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37751, serial#: (b)(4), product type: recharger.Product id: 37712, serial#: (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 37743, serial#: (b)(4), product type: programmer, patient.Other relevant device(s) are: product id: 37751, serial/lot #: (b)(4); product id: 37743, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for non-malignant pain and chronic low back pain.The consumer reported that they had poor communication with the ins recharger when trying to recharge implant.It was reported that the stimulation had stopped.The patient reported that they had a sudden loss of stimulation and everything quit working two weeks ago from (b)(6) 2018.The patient reported that they were sent new recharging equipment but that has not resolved the issue.The patient reported that they had blank screen on the patient programmer then poor communication.It was reported that there was poor communication with the ins recharger on another implant.The patient reported that the antenna cord was damaged on the ins recharger.The patient reported that they have a return of pain in the tailbone up back to the neck.The patient reported that the last time they had a successful charge was three weeks ago.

Manufacturer Narrative

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

Event Description

Additional information was received from a representative (rep) regarding the patient.It was reported that the rep met with the patient on (b)(6) 2018.The rep stated they were unable to recover the implantable neurostimulator (ins) to functioning.The patient reported they saw an elective replacement indicator (eri) message on the recharger about a month prior, but they decided to ignore it.The rep instructed the patient to make an appointment with the healthcare professional (hcp) to discuss ins replacement.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a representative (rep) and a consumer regarding the patient.It was reported that the rep met with the patient on (b)(6) 2018.The rep stated they were unable to recover the implantable neurostimulator (ins) to functioning.The patient reported they saw an elective replacement indicator (eri) message on the recharger about a month prior, but they decided to ignore it.The rep instructed the patient to make an appointment with the healthcare professional (hcp) to discuss ins replacement.

Manufacturer Narrative

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

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 received from the rep stated that no additional info and no further follow up is possible unless the patient returns calls which is doubtful, since the patient hasn¿t returned either one so far.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 7626419
• MDR Text Key: 112201468
• Report Number: 3004209178-2018-14032
• 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,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR