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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Seroma (2069); Discomfort (2330)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 977a275, serial# (b)(4),implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type lead.Product id 977a275, serial# (b)(4) implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a275, serial/lot #: (b)(4), ubd: 13-jun-2019, udi#: (b)(4); product id: 977a275, serial/lot #: (b)(4), ubd: 08-apr-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient experienced painful and tenderness over the surgical scar in the left gluteal ins pocket.The device was repositioned multiple times due to patient having discomfort over the ins site.There was a suspected abscess in the left gluteal ins pocket/left buttock region where the ins was lastly located.The event resulted in an unscheduled clinic or office visit, er visit, and in-patient hospitalization.On (b)(6) 2017 a surgical revision of the scar was performed; resection of the subcutaneous scar tissue.A sample was taken to bacteriology, which was positive for infection.Culture was positive for growth of coagulase, but (b)(6) for (b)(6).On (b)(6) 2017 the patient reported pain and discomfort.Fluid accumulation was found around all components of the spinal cord stimulation system.It was decided to completely remove the ins and two spinal cord stimulation electrodes.The event was not related to the device or therapy, but related to the implant procedure.The outcome was resolved without sequelae on (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) of a clinical study via a company representative (rep) reporting that the exact cause was not determined, but indicated etiology of surgery/anesthesia.

• 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: 7421207
• MDR Text Key: 105141657
• Report Number: 3004209178-2018-07764
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Date Device Manufactured: 01/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 86