MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 10-mar-2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 10-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the caller was currently in operating room caller reports physician had a difficult time removing the ins from pocket so he used a cap and clamped down on the lead (0-7 lead) to remove the ins.Caller reports the ins came out of the pocket but is now having difficult time removing the 0-7 lead from the ins port.Caller reports saline was used and rotating the ins back and forward did not resolve.Caller reports physician used the clamp and was successful in removing the 0-7 lead out of the ins port.Caller reports physician inserted the 0-7 lead into the 8-15 port of the wens.Electrode impedance tested on both leads on the wens, rotating the 8-15 lead on multiple different position, all within normal limits.Electrode impedance tested on the ins all within normal limits.The troubleshooting steps that were taken on the call resolved the issue.Caller reported she is currently in operating room, ins battery replacement due to overdischarge, unrecoverable.

Event Description

The rep reported that the overdischarge was due to noncompliance with charging.Lead removal difficulty from existing ins was suspected to be due to using a clamp to remove battery from incision, but unable to prove with certainty.Ins was discarded.

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: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11849214
• MDR Text Key: 251427307
• Report Number: 2649622-2021-10016
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 06/08/2021

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: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention