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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Interrogate (1332); No Device Output (1435); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2020

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 regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had a problem getting their patient programmer to sync with their ins for ¿about maybe four months,¿ they stated ever since they had to go through the airport screeners.They stated that they showed them their mdt card, butthey still made them go through the screeners twice and they didn¿t turn the ins off.The patient tried to use their patient programmer during the call and the patient got the poor communication screen without the antenna and were not able to try it with the antenna as they stated it was broken/not working (see pe 703866502).The patient then tried to use their recharger and they got the reposition antenna screen even after trying multiple times.Patient services asked the patient when the last time they charged the ins and they stated last night; however, it was not clear if they actually did because they mentioned seeing a screen with arrows when trying to recharge.They stated that they had been seeing the reposition antenna off and on ever since they went through the airport screeners and now that was all they see.The patient stated that they had not been able to turn the ins on with either the patient programmer or recharger.Patient services redirected the patient to follow-up with their healthcare provider (hcp)/manufacturer representative (rep) to check the ins as they were not able to connect with either external device and has had trouble since going through the airport.The event occurred in 2020.

• 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: 10323222
• MDR Text Key: 200319222
• Report Number: 3004209178-2020-12828
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Date Device Manufactured: 11/19/2015
• 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: 54 YR