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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial#: (b)(4), product type: recharger.Other relevant device(s) are: product id: 97754, serial/lot #: (b)(4), udi#: (b)(4).Date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).The patient reported that their recharger (insr) didn¿t work.The patient reported that a manufacturer¿s representative (rep) said they needed to coordinate getting them into their healthcare provider (hcp) when the rep was there yesterday, but the rep didn¿t call them back.The patient was in a lot of pain and he needed to get a hold of the rep.The patient reported that the insr wasn¿t showing anything on the screen.The patient declined assistant with the equipment over the phone.Additional information was received from the patient and rep.It was reported that the insr needed to be replaced because it was damaged.The patient called back later with their insr and reported that it was not charging for 3 weeks.During troubleshooting it was found that the desktop charger (dtc) cord was loose.Repair noted that the insr would not power on.A replacement insr and dtc were sent to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on may 21st, 2020.It was reported that the patient received the implantable neurostimulator recharger (insr) and desktop charger (dtc), and they are working.He also needs a programmer.The patient mentioned that the programmer was not getting black boxes.He clarified that the programmer was not showing anything and he changed the batteries.During troubleshooting on the call, the patient was instructed to press the power button.The "sync now" screen came up.The patient tried connecting to the implantable neurostimulator (ins), but the programmer kept showing the sync screen.A replacement programmer was sent to the patient.There were no further complications or anticipations reported with this event.

Manufacturer Narrative

Continuation of d11: product id: 97740, serial# (b)(6), product type: programmer; patient product id: 9 7754, serial#(b)(6), product type: recharger; product id: 37761, serial# (b)(6), product type: recharger.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 the patient.They provided their weight at the time of the event.They stated the replacement equipment resolved the issues.No patient complications were reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 97740 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 9 7754 lot# serial# (b)(6) implanted: explanted: product type recharger product id 37761 lot# serial# (b)(6) implanted: explanted: product type recharger h3:the recharger (serial# (b)(6)) was analysis and found to have no anomaly.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 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: 10079198
• MDR Text Key: 191732676
• Report Number: 3004209178-2020-08955
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2020

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: 12/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 05/21/2020; 06/02/2020; 06/05/2020
• Supplement Dates FDA Received: 05/25/2020; 06/03/2020; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 72 YR
• Patient Weight: 75