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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2020

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 consumer concerning patient with an implantable neurostimulator (ins).It was reported patient has been having issues with his stimulator automatically shutting itself down, which happens around once a day (a couple days ago this happened 8 times during the day).He said stimulation will be running when he notices it has turned off, and when he looks at patient programmer, he sees the setting shows all 0s.Patient said this started 4-6 months ago and has not had any falls or trauma to the ins site.He said he has been to his pain clinic already and his doctor and rep have checked ins, but when rep checked it, she said nothing showed up that showed there was a problem.Patient said when rep checked ins, they reset the program he uses the most (patient said he has two programs and the issue occurs on both: one has two settings - the one he uses the most, and the other has 4 settings).Patient then said he reset all the stimulation levels as well afterwards (patient said he uses adaptivestim).The patient said the stimulation automatically turning off happens in every position (walking, sitting, laying down) and at any time of day.He said it usually happens when he has been in a position for a while, not when he is changing positions.Patient said sometimes stimulation will turn back on after a few seconds, and other times it can take 5-15 minutes, but does turn back on by itself.As patient has already tried the different programs and setting adaptivestim, patient was redirected to the healthcare provider (hcp).Additional information was received from the manufacturer representative (rep).It was reported it was determined that the changes in sensation was most likely due to his adaptive stim (patient described changes of stimulation due to position).Adaptive stim was recalibrated and patient was instructed to call back if he was still having issues.Patient's weight was unknown.The cause of ins turning off by itself and the settings decreasing to 0 was not determined.Patient had described it as changes in sensation.Adaptive stim recalibration was performed.The patient was instructed by healthcare provider (hcp) to journal occurrences and make a follow up appointment.

• 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: 10341429
• MDR Text Key: 200968906
• Report Number: 3004209178-2020-13096
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Date Device Manufactured: 12/23/2015
• 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: 66 YR