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); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

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 regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the ins was not working and not charging.The caller said there was poor communication and the patient was seeing the reposition antenna screen on the recharger; the caller noted that the recharger was charging 1/4 of the way.The caller also reported that the patient was not feeling stimulation.The caller stated that the patient had tried to charge ins and recharger was not charging the ins.The patient said they had done everything they can to charge the ins.The patient also tried to connect with the programmer but the programmer wouldn't connect.The caller said that the ins wouldn't charge a couple weeks prior to the report and a couple weeks before that is when the patient last successfully charged the ins.The patient said they stopped feeling stimulation and they were in pain; the patient said that their ins was for the patients right leg and butt cheek.The patient stated that the ins does relieve the pain however the stimulation was not on as the ins needed to be charged.The patient said their healthcare professional was no longer at that office but they would go to that same office.Additional information as received from a manufacturer¿s representative (rep).The rep reported that the patient¿s battery was overdischarged.The rep reported that the patient hadn't charged in a very long time.The battery was interrogated and a trickle charge was initiated.The issue was noted to be resolved.Additional information was received from the patient.The patient reported that the recharger couldn't find the battery, so he could charge it.The patient reported that he had trouble with it since the battery was changed in 2015.The patient reported that he called and set up an appointment with the pain center and a manufacturer¿s representative (rep) came and they still couldn't get the charger to find the battery so they would have to change the battery again.The patient reported that the issues weren't yet resolved but they were working on it and they had to get work comp to ok the procedure.Additional information was received from the manufacturer representative.It was reported that the trickle charge was unsuccessful and the patient was getting the battery replaced.No further complications were 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: 7594200
• MDR Text Key: 110855949
• Report Number: 3004209178-2018-13265
• 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
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2018
• Date Device Manufactured: 11/06/2014
• 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