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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on february 18, 2020.They reported the healthcare provider (hcp) had informed them about the lead migration and coiling on the day of the surgery, which was february 3, 2020.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 08-dec-2019, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had a spinal fusion of l4, l5 and s1 (unrelated to the device/therapy) in (b)(6) 2019, and during that surgery the surgeon removed part of the lead.Sometime after that surgery, the lead migrated and coiled up in the spine.On (b)(6) 2020, the patient had surgery to replace the lead.The lead could not be removed from the epidural space on (b)(6) 2020 due to scar tissue, so the lead was abandoned.The ins was replaced as a preventative measure and it was confirmed there were no allegations/complaints against the ins.Following the lead replacement surgery, the patient was able to get 90% pain relief.No further complications were reported or anticipated.

• 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: 9722072
• MDR Text Key: 185412274
• Report Number: 3004209178-2020-03568
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2016
• 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: 100