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

Model Number 37711

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2009

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2008, product type: lead.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 08-apr-2012, udi#: (b)(4); product id: 3778-60, serial/lot #: (b)(4), ubd: 24-mar-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and failed back syndrome - other.Patient states falling frequently due to fused ankles and inability to feel bottoms of feet.States scs worked well but after multiple leads migrated.States meeting with reps to attempt reprogramming but unsuccessful.Patient felt stimulation at bottom of spine only, never able to target desired feet and ankle areas. at this point in time, patient wants to just have scs leads and ipg removed.Patient medical history included clubbed feet, feet and ankle surgeries in nerves were severed, crps bilateral feet and legs which has progressed to full body.

• 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: 11643806
• MDR Text Key: 244726374
• Report Number: 3004209178-2021-05790
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2008
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Date Device Manufactured: 11/21/2007
• 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: 48 YR
• Patient Weight: 127