MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: (b)(4), product type: recharger.Product id: 37761, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.It was reported that they noticed around (b)(6) 2020 that they were unable to charge their implantable neurostimulator (ins) unless they were plugged into the desktop charger.The patient reported that the piece above the connector pin was very loose when plugged into the recharger and the ins battery was currently depleted.When the patient had the desktop charger plugged into their recharger, it was showing that there was an active charging session on the recharger.The patient stated that they had the recharger plugged in for five hours but the recharger was not charging and the recharger battery level was not incrementing.The patient stated that they had the desktop charger plugged into the recharger and tried to start a charge session but the recharger showed that the recharger battery was too low to charge the ins or recharger.It was reported that the patient was last able to charge their ins on the weekend prior and felt stimulation until (b)(6) 2020 but did not feel stimulation on the date of this report.The repair department was contacted and a replacement recharger and desktop charger were requested.No further complications were reported or anticipated.Indication for use is non-malignant pain.

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.

Event Description

Additional information was received from patient who were asked about steps taken to resolve the loss of stim, patient stated that a manufacturer rep had patient go through a series of steps to first list her existing unit.Replacement recharger and charger were sent, after she ultimately determined that would be necessary.Patient said when she first received it, rep needed to super charge, but after that everything was great ever since.No symptoms were reported.No further complications were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10071087
• MDR Text Key: 191447916
• Report Number: 3004209178-2020-08808
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 55 YR
• Patient Weight: 57