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

Model Number 97714

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Impedance Problem (2950); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c265, (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).It was reported that the patient was not receiving any stimulation benefits from the old system.The lead was placed too far left.The patient had difficulty recharging.It was noted that the battery was discharged at the time of surgery.It was mentioned by the surgeon that there may have been a high impedance problem with the old system, but were unable to determine the high impedances at the time of the surgery.The lead was replaced.An impedance check was run with the old leads connected to the new battery and the level was normal.The lead was replaced to be safe.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient who was implanted with a neurostimulator for spinal pain and failed back surgery syndrome.It was reported that the patient did not get any therapeutic relief from the previous system.The consumer reported that it was eventually discovered that ¿it was bent and not connected.¿ this information is contradictory to the information received at the time of the replacement on (b)(6) 2018.There were no further complications reported or anticipated.

Event Description

Additional information was received.It was reported the patient was referred to a surgeon to replace the ins as there was a problem.The patient then stated it was found that the electronic impulse was not making a complete circuit.The patient noted it had become detached and was kind of floating around.The patient noted that was in 2018 and they had the ins replaced in 2018.

Manufacturer Narrative

Continuation of d10: product id: 977c265, serial#: (b)(6), implanted: 2017 (b)(6), explanted: 2018(b)(6), product type: lead.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): 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: 7766959
• MDR Text Key: 116538789
• Report Number: 3004209178-2018-17691
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2022
• Date Device Manufactured: 12/27/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female