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

Model Number 37714

Device Problem Connection Problem (2900)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3708220, serial#: (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3708220, serial#: (b)(4), implanted: (b)(6) 2012, product type: extension.Other relevant device(s) are: product id: 3708220, serial/lot #: (b)(4), ubd: 08-dec-2015, udi#: (b)(4) ; product id: 3708220, serial/lot #: (b)(4), ubd: 27-sep-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an other pain indications-other.It was reported that the rep was in the or for an ins replacement, but the rep stated that one of the extensions would not come out of the ins header block.Technical services reviewed configuration based on registration data.The caller asked about using a new lead.Technical services reviewed that it would work, but if the leads were ok they could just replace the extension.It was indicated that the rep had the extensions with him the rep spoke to the doctor and they say that they would only be using one port of the new ins today and would revise the leads or extensions at another time.No symptoms were reported.The event occurred on (b)(6) 2019.Additional information was reported that there was difficulty/unable to disconnect components during the ins replacement.The lead/extension would not disconnect from the ins.It was reported that one of the leads came out of the ins without issues, but the other one was not coming out and was stuck.It was suggested to attempt to use sterile water as lubricant and twisting the lead while pulling it out.It was confirmed that the set screw was all the way loosened and while discussing this, the physician in the background stated, ¿it didn¿t matter now, the lead already busted¿ and it was ¿not coming out of that¿.The physician had indicated that they had completely removed the set screw and could see that it was loose inside the silicone.At this point, the rep didn¿t request any further assistance and ended the call.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 3708220, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: extension; product id: 3708220, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the customer discarded the explanted ins.The cause of the ins not being able to be disconnected was not determined nor was the cause of the ¿extension/lead busting¿ determined.It was reported that the issue had been resolved.The physician connected the one extension that was not cut and the patient was satisfied with their relief.It was reported that this was initially reported during surgery.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 3708220, serial# (b)(4).Implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type extension product id 3708220, serial# (b)(4), implanted: (b)(6) 2012.Product type extension adverse event or product problem: updated to only adverse event.(surgery/revision no longer planned/needed) outcomes attributed to adverse event: update: no outcome attributed to adverse event applies type of reportable event: updated type of reportable event to malfunction as surgery/revision no longer planned/needed 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 representative (rep) clarifying that there was no additional procedure scheduled to revise the leads or extensions at another time as the originally reported due to the patient being able to obtain adequate relief with one port being utilized.It was indicated that the extension that was unable to be disconnected from the ins was not completely explanted, it was only cut.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

• Brand Name: RESTORE SENSOR
• 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: 9248092
• MDR Text Key: 165962337
• Report Number: 3004209178-2019-20587
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR