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

Model Number 37712

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8880t2, serial #: (b)(4), product type: accessory.Report source: country: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that error code 575 ¿ ¿eeprom corrupted¿ message was observed on a recharger.A physician recharge mode (prm) was attempted, but the message still appeared on the recharger and a physician programmer.It was noted the issue had occurred the ¿last week¿ prior to report.The patient experienced ¿less than 50% therapy relief¿ and error code 575 was reported with the implantable neurostimulator (ins).The error code was observed on a recharger.A physician mode recharge (pmr) was attempted eight times, but there was no response.It was unknown whether any external factors led or contributed to the issue; the issue remained unresolved at the time of report.The cause of the 575 error code was undetermined as of (b)(6) 2019.There was no hospitalization required and the patient was alive with no injury at the time of report, though the patient was without therapy as of (b)(6) 2019.It was noted that as of (b)(6) 2019, the patient¿s ins has been replaced.There were no further complications reported or anticipated.

Event Description

Additional information received reported the ins was replaced on (b)(6) 2019 and the issue was resolved.There were no further compl ications reported or anticipated.

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.

• 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: 8354160
• MDR Text Key: 136639513
• Report Number: 3004209178-2019-03597
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2013
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention