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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a1, lot#: 0210061309, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 977a1, serial/lot #: (b)(4), ubd: , udi#:.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient experienced overstimulation in the neck due to the lead.Imaging was performed which discovered lead migration.Etiology was possibly related to the device or therapy, and not related to the implant procedure.The lead was repositioned, and the extension was explanted and not replaced on (b)(6) 2017.The outcome was resolved without sequelae.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12061281
• MDR Text Key: 262899653
• Report Number: 3004209178-2021-09935
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• Date Device Manufactured: 01/22/2016
• 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: 53 YR