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

Model Number 97714

Device Problems Failure to Power Up (1476); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: unknown, 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 (pt) regarding an external device for an implantable neurostimulator (ins).It was reported that the recharger stopped working and was not doing anything.They were able to connect to their ins with their patient programmer, but when they tried to connect with the recharger the screen would remain blank.They said they were in really bad pain and really cramping since they weren't able to recharge.The patient inspected the desktop charger and said the green light on the desktop charger was on.The connector pin was not bent and was not wobbly.It was noted the recharger was unresponsive.The issue was not resolved.Additional information was received from a consumer and manufacturer representative and it was reported that the caller had a damaged desktop charger cord.The patient reported that the recharger doesn't power on and desktop charger cord was loose and this started about 3 weeks ago.The patient said they are hurting because the part broke, and also because they are recovering from neck surgery which was on tuesday of this week.

Manufacturer Narrative

Concomitant medical products:product id 37761 lot# serial#(b)(6)implanted: explanted: product type recharger product id 37751 lot# serial#(b)(6) implanted: explanted: product type recharger product id 37751 lot# serial#(b)(6) implanted: explanted: product type recharger product id 37751 lot# serial#(b)(6)implanted: explanted: product type recharger product id 37761 lot# serial#(b)(6) implanted: explanted: 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 reported from the patient via a letter.A part was sent to replace the broken recharger, but an entirely new unit (recharger) was promised.They stated theirs had been broken so often even though they were so careful when charging it.Additional information was received.Information was received from a manufacturer's representative (rep) via a patient regarding an external device.The reason for call was the patient was not able to charge the ins.The caller indicated that the patient had the recharger connected to the ac adapter for a couple of days and the recharger does not turn on.The caller plugged the recharger into the ac adapter and then it was showing a screen indicating that the insr need to be charged.The caller tried to start a charging session and the patient reported that they could feel tingling in their finger while the rep was trying to recharge.The caller connected the insr to a second ac adapter and then was able to start a normal charging session.The caller indicated that the patient had another recharger and the dtc connector pin was broken.The issue was not resolved through troubleshooting.

Manufacturer Narrative

B3: date is approximate.Continuation of d10: product id: 37761, serial# (b)(6), product type: recharger; product id: 37751, serial# (b)(6), product type: recharger; product id: 37751, serial# (b)(6), product type: recharger; product id: 37751, serial# (b)(6), product type: recharger; product id: 37761, serial# (b)(6), product type: recharger.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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

Information was received from a patient (pt) regarding an external device for an implantable neurostimulator (ins).It was reported that the recharger stopped working and was not doing anything.They were able to connect to their ins with their patient programmer, but when they tried to connect with the recharger the screen would remain blank.They said they were in really bad pain and really cramping since they weren't able to recharge.The patient inspected the desktop charger and said the green light on the desktop charger was on.The connector pin was not bent and was not wobbly.It was noted the recharger was unresponsive.The issue was not resolved.Additional information was received from a consumer and manufacturer representative and it was reported that the caller had a damaged desktop charger cord.The patient reported that the recharger doesn't power on and desktop charger cord was loose and this started about 3 weeks ago.The patient said they are hurting because the part broke, and also because they are recovering from neck surgery which was on tuesday of this week.Additional information was reported from the patient.A part was sent to replace the broken recharger, but an entirely new unit (recharger) was promised.They stated theirs had been broken so often even though they were so careful when charging it.Additional information was received.Information was received from a manufacturer's representative (rep) via a patient regarding an external device.The reason for call was the patient was not able to charge the ins.The caller indicated that the patient had the recharger connected to the ac adapter for a couple of days and the recharger does not turn on.The caller plugged the recharger into the ac adapter and then it was showing a screen indicating that the insr need to be charged.The caller tried to start a charging session and the patient reported that they could feel tingling in their finger while the rep was trying to recharge.The caller connected the insr to a second ac adapter and then was able to start a normal charging session.The caller indicated that the patient had another recharger and the dtc connector pin was broken.The issue was not resolved through troubleshooting.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12285007
• MDR Text Key: 265375749
• Report Number: 3004209178-2021-11987
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: 08/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 11/16/2021; 07/29/2021
• Supplement Dates FDA Received: 11/24/2021; 02/22/2024
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H11...."
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG