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

Model Number 97713

Device Problems Migration or Expulsion of Device (1395); Inadequate Instructions for Non-Healthcare Professional (2956); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient in a clinical study with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that it was no longer providing relief; actions taken included explanting and not replacing the system.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015.Product type lead, product id 977a260, serial# (b)(4), implanted: (b)(6) 2015.Product type lead.Device evaluation conclusion code pertains to lead 977a260 5mm compact 1x8 mri ((b)(4)) and lead 977a260 5mm compact 1x8 mri ((b)(4)).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins).It was reported on (b)(6) 2015 the patient had less pain relief than he got with the trial.The patient reported the pain relief to the bilateral legs with the left leg was better than the right leg.The hcp noted the left lead migrated down 1 vertebral body with the tip being at t8 and the right lead had migrated down approximately ½ vertebral body with the lead tip about mid bottom t7.It was noted the event was related to the device or therapy and was not related to the implant procedure.It was noted the leads were repositioned on (b)(6) 2015.The hcp noted the event was resolved without sequalae on (b)(6) 2017.It was noted the lead migrated/dislodged.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Product id 977a260, serial# (b)(4) implanted: (b)(6) 2015, explanted: (b)(6) 2015.Product type lead, product id 977a260, serial# (b)(4) implanted: (b)(6) 2015, explanted: (b)(6) 2015.Product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) in a clinical study (sdy).It was reported that the device was ineffective at providing relief.It effectively treated their radicular leg symptoms, but not their axial back pain.Since the implant, they had undergone three level lumbar fusions by a hcp, which completely relieved their leg pain, but not the back pain.This was resolved on (b)(6) 2017 when it was explanted.It was further reported that the leads were explanted on (b)(6) 2015.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via manufacturer representative.It was reported that the exact cause of it no longer providing relief was not known.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) in a clinical study (sdy).It was reported that the leads weren't explanted/replaced; rather, they were repositioned.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8294638
• MDR Text Key: 134655557
• Report Number: 3004209178-2019-02183
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 02/05/2019; 03/25/2019; 05/30/2019
• Supplement Dates FDA Received: 02/01/2019; 02/07/2019; 03/28/2019; 06/11/2019
• Date Device Manufactured: 01/08/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 123