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

Model Number 37714

Device Problems Break (1069); Disconnection (1171); Battery Problem (2885); Charging Problem (2892)

Patient Problems Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3777-45, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 3777-45, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead.Other relevant device(s) are: product id: 3777-45, serial/lot #: (b)(4), ubd: 03-feb-2015, udi#: (b)(4).Product id: 3777-45, serial/lot #: (b)(4), ubd: 22-sep-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient (pt) said she needs an mri for other problem, but she can't charge ins/get mri mode on pp.She said the mri is because her right leg is numb, and they are trying to figure out why.Pt also mentioned her leads are in the occipital part of her head.Patient services (pss) reviewed mri guidelines with pt.Pt said a couple of the leads broke about a year ago (confirmed last year),and clarified a connection was broken.Pt said her rep met with her and turned off the lead section that was not working and she tried to keep it going, but then earlier this year during the pandemic, her battery died and she has not been able to get ins to charge since.She said they were going to have internal components changed out, but then the pandemic hit so she hasn't been able to yet.

• Brand Name: RESTORE SENSOR
• 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: 10969254
• MDR Text Key: 220248362
• Report Number: 3004209178-2020-21404
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: 12/08/2020

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: 04/14/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/08/2020
• Date Device Manufactured: 05/22/2014
• 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: 49 YR