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 High impedance (1291); Connection Problem (2900)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2019, product type: lead.Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 27-apr-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The rep reported that the patient¿s ins had a normal elective replacement indicator (eri)/normal depletion.The rep reported that is was known that impedances were greater than 10,000 ohms on electrodes 0, 4, 10 and 12.The rep reported that the patient was able to receive normal/needed therapy without utilizing those electrodes.The rep reported that the plan was to just replace the battery.The rep reported that upon trying to remove the battery from the lead, the surgeon had difficulty pulling the lead out.Then there was much difficulty placing the old lead into the new battery.The rep reported that there were many red ¿x¿s¿ on the connection test, including electrodes used for the patient¿s normal programming.The rep reported that the surgeon attempted multiple times to place the lead into the new battery and the contacts were wiped off multiple times.The rep reported that it was decided that the entire system should be replaced by poor/difficult connection/placement of lead into the new battery.The issue was resolved.No further complications were reported.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3550-39 and product type: accessory.Product id: 3550-39 and product type: accessory.Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2019 and product type: lead.Product id: 97715, serial# (b)(4), implanted: (b)(6) 2019 and product type: implantable neurostimulator.Device evaluated by mfr: analysis results were not available at the time of this report.A follow up report will be sent once analysis complete.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 received from a manufacturer¿s representative (rep).The rep reported that the healthcare provider (hcp) wasn¿t able to seat the old lead into the new battery and it was also very difficult to remove the old lead from the old battery.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id neu_siliconeanchor lot# unknown product type accessory product id n eu_siliconeanchor lot# unknown product type accessory product id 39565-65 lot# serial# (b)(6) implanted: (b)(6) 2011 explanted: (b)(6) 2019 product type lead product id 97715 lot# serial# (b)(6) implanted: (b)(6) 2019 product type implantable neurostimulator h3.Analysis of the implantable neurostimulator (ins) nkf734825h found the stimulator battery to be at normal end of life/eri or eos (rechargeable ins).Analysis of the lead (b)(6) found that the insulation on the proximal end of the lead was consistent with metal ion oxidation (mio).Analysis found degraded insulation (mio), category 3 on both leads legs.This would make it difficult to fully insert the lead into the replacement ins and most likely the cause of the set screw marks that are too proximal (located on connectors 1 and 9).There are also set screw marks in the correct location on connector 0 and connector 9.H6: prior conclusion code, results code and method codes no longer apply.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: 9311254
• MDR Text Key: 172588612
• Report Number: 3004209178-2019-21606
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR