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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 crts 3883714 (hcp): information was received from a healthcare provider (hcp) regarding a patient's implantable neurosti mulator (ins) for spinal pain in (b)(6) 2019.It was reported that the patient's external equipment was stolen and the ins didn't work.The hcp wasn't able to clarify what was meant by "doesn't work" but they assumed it had been a while since the patient charged the ins.No symptoms or further complications reported.Additional information was received from the patient in august 2020 reiterating that they had lost all of their equipment three years ago and their ins stopped working all together six months after having it implanted.They stated that now they needed their equipment so they could charge the ins for a procedure they were having on their shoulder.The event occurred in 2017.On june 15, 2021, additional information from the patient indicated that they need to meet with someone to get the ins "woken up." they stated that it has been dormant for 4 years.On (b)(6) 2021, the patient called back requesting information on how to get their battery "jump started".Pt mentioned on the call that they just got replacement external equipment for their device.Pt said that just about a month ago they tried to charge their implant and they were unsuccessful.Pt s aid that they have no managing hcp at this time.Then, on (b)(6) 2021, the manufacturer representative (rep) was made aware that the patient hadn't charged the ins for a "couple years", so it had gone dead.As a result of it going dead, the ins was replaced.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12454442
• MDR Text Key: 271692655
• Report Number: 3004209178-2021-13671
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/10/2021
• Date Device Manufactured: 03/08/2017
• 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: 45 YR