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

Model Number 97714

Device Problems Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient's battery worked sometimes, but sometimes it worked in their legs and they didn't want it in their legs.They stated that they wanted it in their spine, because when it is in their legs it gives them no balance.The patient stated that they felt it in their legs and their legs shake sometimes.The patient stated that they were having a lot of pain in their back.They stated that because they were not able to charge their implant they were having pain.The patient was redirected to follow up with their healthcare provider (hcp) to further address the issue.Information was also received from the patient regarding an external device, as the patient stated that their battery was dead.They mentioned  that they charged the battery and it was not working.The patient stated that they wanted someone to come to their doctor's office.They stated that they had an appointment on the 21st.The patient stated that the battery was almost empty.The patient reported they maybe pressed some buttons by mistake and it didn't charge.They were going to bring the recharger with them to their doctor and they can see what happens.The patient asked if the battery if it would cause pain.The patient mentioned they had pain in their back since the end of december.Troubleshooting was unable to be performed as patient services offered to help over the phone, but the patient did not want assistance and wanted to meet someone in the office instead.The patient noted that they were too old to use the equipment and doesn't know anything about using it.

• 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: 11178929
• MDR Text Key: 227531512
• Report Number: 3004209178-2021-00884
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Date Device Manufactured: 01/30/2015
• 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 Age: 70 YR