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

Model Number 97702

Device Problem Electromagnetic Interference (1194)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3550-39, lot# n504986, implanted: (b)(6) 2015, product type: accessory.Product id 3 9565-65, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 3550-39, serial/lot #:(b)(4), ubd: 22-oct-2018, udi#: (b)(4).Product id: 39565-65, serial/lot #: (b)(4), ubd: 30-jul-2019, udi#: (b)(4).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) for unknown indications for use.It was reported that¿she had talked to her health care provider (hcp) about getting an mri and was told that her battery was mri compatible but her leads weren't and ultimately was told that with the device she shouldn't have mri's at all, patient said she had been ok'd to have several mris in the past, mentioning mri of knee/head/back had been done.Patient said that she's had traumatic brain injuries so she had a lot of memory loss and had not remembered that she wasn't supposed to get mri's and ended up getting a head mri when she went to the er in (b)(6) 2021.Patient reported that she had severe pain where the leads were for over a year now and the cause of this was unknown, no one had been able to figure out why patient was having pain.Patient said she wondered if this was related to or caused by having mris.Patient said that lead pain got worse after she had the last head mri in (b)(6) 2021.Patient said she talked to her neurologist about this and he told her from this point on to not have any mri's.

• 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: 11725299
• MDR Text Key: 247695955
• Report Number: 3004209178-2021-06682
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Date Device Manufactured: 08/03/2015
• 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