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

Model Number 97713

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)

Patient Problem Headache (1880)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

See regulatory report 3004209178-2021-04677 for same event on a second device implanted in the same patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative regarding an implantable neurostimulator (ins).It was reported that the patient's two implants were in overdischarge.The patient reported not being able to charge either of her devices.The manufacturer representative (rep) reported they were able to jump both her lumbar ins and the occipital battery.The rep also reports they did a diagnostic test on both devices and impedances were > 10,000 ohms.The patient reports that she has had several falls due to a bad knee.It was reported that no other interventions were done at the time, as the patient is going to set up and appointment with her healthcare provider to discuss replacement.The patient reported that she would like to have the occipital implant again as her headaches are the worst of her pain at the moment.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11543675
• MDR Text Key: 241487411
• Report Number: 3004209178-2021-04679
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Date Device Manufactured: 03/03/2017
• 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 Age: 73 YR