MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37711

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37711, serial#: (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 3777-45, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3777-45, serial/lot #: (b)(4), ubd: 29-mar-2015, udi#: (b)(4); product id: 3777-60, serial/lot #: (b)(4), ubd: 31-mar-2015, udi#: (b)(4); product id: 3777-60, serial/lot #: (b)(4), ubd: 28-sep-2014, udi#: (b)(4); product id: 3777-60, serial/lot #: (b)(4), ubd: 03-feb-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that the entire system was removed around (b)(6) 2019 because two of the wires let go.The patient stated this caused her to feel like she was being lit up whenever she turned the implant on.The patient wanted to get an mri scheduled and mentioned she had an x-ray prior to being prescribed the mri that verified she didn't have any leads implanted currently.

• Brand Name: RESTORE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 10351166
• MDR Text Key: 201902295
• Report Number: 3004209178-2020-13233
• Device Sequence Number: 1
• Product Code: LGW
• 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: 07/31/2020

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: 05/14/2012
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 07/31/2020
• Date Device Manufactured: 04/18/2011
• 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: 50 YR