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

Model Number 97714

Device Problems Loss of Power (1475); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Occupation: healthecare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - nonmalignant pain.It was reported that the patient was having an mri due to sepsis from the spinal cord stimulation infection.The healthcare provider reported that the patient's patient programmer was currently dead.Technical services reviewed replacing batteries to access mri mode.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that on (b)(6) 2018.There was an emergency surgery to remove the cervical wires and ins battery.The patient said they were in the hospital from (b)(6) and also from (b)(6).The patient was given iv antibiotics and oral antibiotics and there was drainage of a fluid pocket on (b)(6).The patient reported that the sepsis/infection had been resolved as blood counts were in normal limits and they were waiting on a last set of cultures.No further complications were reported/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: 7751931
• MDR Text Key: 116073981
• Report Number: 3004209178-2018-17433
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/10/2015
• 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): Other; Required Intervention
• Patient Weight: 97