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); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Scar Tissue (2060); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had had their stimulation turned off for several months.They attempted to connect to the ins and went through the antenna locate process many times on their own, but they weren't able to start a normal charging session.The patient had their stimulation turned off because they were getting to a point that they didn't need it anymore.The patient stated that they were in trouble because they were in the middle of charging the recharger and the desktop charger metal tip broke off.The patient programmer didn't indicate mri eligibility they saw a triangle, a book, and a bunch of numbers.They saw a splash screen, which resolved with replacing the patient programmer batteries.Mri mode came up with cannot be determined code 0 47 07 10 10 10 indicating abandoned leads and the patient believed they were full body eligible.No symptoms were reported.No further complications were reported or anticipated.Additional information was received from a patient.It was reported that patient could not have a magnetic resonance imaging because the healthcare professional (hcp) left in old leads.He could not remove them because of excessive scar tissues.No steps to resolve issue were reported.The issue was not resolved.No further complications were reported.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10094857
• MDR Text Key: 192379642
• Report Number: 3004209178-2020-09248
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Date Device Manufactured: 07/24/2017
• 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 Age: 68 YR