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

Model Number 97702

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had turned their stimulator to where they normally have it, and then when they went to lower the amplitude for laying down, as they cannot have the settings as high, they saw a message saying to ¿call their doctor¿.They stated that they changed the batteries, but they stated that it does not feel as if the stimulator was working at all.On the call the patient was seeing the message for elective replacement indicator (eri) and when the patient services had the patient clear the message they were then seeing end of service (eos).No traumas/falls were reported to be related to the issue.There was also no allegation/dissatisfaction with the ins longevity.It was reported that since sometime in (b)(6) 2019, they had been waking upand having pain where their stimulator was and it usually was not like that.The eri screen was reported to have been seen on (b)(6) 2019 and the eos was seen during the call.The patient was redirected to follow-up to discuss their eos with their healthcare provider (hcp).Additional in formation was reported that the doctor is still waiting to see the patient, but they will likely replace the ins.The pain at the implant site causing the patient to wake up has not been resolved at this time.No further information was reported.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient's ins will be replaced, but no date has been scheduled yet.The patient's pain at their ins site has not been resolved yet.It was noted that the patient denied their battery reaching end of life.No further information was reported.

• 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: 9681261
• MDR Text Key: 178135847
• Report Number: 3004209178-2020-02799
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Date Device Manufactured: 08/11/2016
• 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: 69 YR