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

Model Number 97714

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

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, regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain and complex reg pain syndrome type i.Caller was an mri tech and stated that patient reported to her that her neurostimulator has not worked in over a year.The caller is not exactly sure what that means.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the patient's ins has not worked since it was implanted due to the leads not being high enough in the patient's cervical spine.No actions have been taken to resolve the issue yet, but it was noted that there were multiple infections with surgeries in the past.The options are going to be discussed with the patient to resolve their issue.No further information was reported.

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead; product id: 977a275, serial# (b)(4), implanted: (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 the hcp.It was reported that (b)(6) after intrathecal pump implant was removed and new one placed.No further complications were reported.

• 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: 9178996
• MDR Text Key: 166544566
• Report Number: 3004209178-2019-19459
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2019
• Date Device Manufactured: 02/15/2017
• 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): Required Intervention
• Patient Age: 30 YR