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

Model Number 37701

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3487a-45, lot #: v166805, implanted: (b)(6) 2009, product type: lead.Product id: 3487a-45, lot #: v166805, implanted: (b)(6) 2009, product type: lead.Product id: 3776-45, serial #: (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 3487a-45, serial/lot #: (b)(4), ubd: 18-oct-2012, udi#: (b)(4).Product id: 3487a-45, serial/lot #: (b)(4), ubd: 18-oct-2012, udi#: (b)(4).Product id: 3776-45, serial/lot #: (b)(4), ubd: 12-may-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported via the manufacturer representative that all of the leads had migrated.It was stated that the eight contact lead was implanted midline with two quad leads on either side.X-rays were obtained and now the eight contact lead and one quad lead were left of the midline and the other quad lead appeared to cross the midline.The hcp noted that the system had stopped working and was ignored for a number of years while the patient dealt with more pressing health concerns.No interventions had been taken so far, but surgery was planned.It was discussed to test the leads intraoperatively and see if the hcp could get a good result with slight manipulation of the eight contact lead.The issue was not resolved at the time of the report.The indication for use was failed back surgery syndrome.No patient symptoms reported.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer representative reported that the cause of the lead migration was not determined.The patient had been scheduled for a full system removal and replacement but the procedure was postponed due to covid-19 and a new date had not been set.

Manufacturer Narrative

Continuation of d11: product id 3487a-45, lot# v166805, implanted: (b)(6) 2009, explanted: (b)(6) 2020, product type lead product id 3487a-45, lot# v166805, implanted: (b)(6) 2009, explanted: (b)(6) 2020, product type lead product id 3776-45, serial# (b)(6), implanted: (b)(6) 2009, explanted: (b)(6) 2020, product type lead.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

Additional information was reported that of the all of the patient's spinal cord stimulator (scs) implants were removed on (b)(6) 2020.They were replaced with a new system.The patient is very happy with the stimulation.His registration has been updated.When the old system came out, everything was intact expect for one anchor.The silicone outer component had come apart from the metal piece that was crimped onto the lead.

• Brand Name: RESTORE PRIME
• 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: 9623008
• MDR Text Key: 185906832
• Report Number: 3004209178-2020-01675
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2009
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 09/21/2020
• Supplement Dates FDA Received: 04/16/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention