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

Model Number 37714

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Charging Problem (2892); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problem Malaise (2359)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37791, serial#: unknown, product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2019, information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator (ins) for spinal pain and failed back surgery syndrome.The patient reported that there was poor coupling.The patient reported that "i haven¿t had my back charged in a couple days and i was so sick yesterday that i didn¿t call then, but it just won¿t charge".The patient mentioned that she had called previously and was sent a new insr antenna (see (b)(4)).The caller was redirected to follow up with their healthcare provider (hcp) for the following reason: the patient is reporting that she is experiencing coupling issues and has already been sent a new recharging antenna.The patient stated that when we sent a new recharger antenna "it worked fora little while" but then had coupling issues again for "the last couple of days" ((b)(6) 2019).Although it was reviewed to follow up with the hcp, the patient still wanted patient services to send a new recharger antenna, so one was sent.Email sent to repair.No symptoms were reported.No further complications were anticipated/reported.On 2019-feb-20, additional information was received from the patient reporting that the patient was sent their recharger antenna in past (b)(6) 2018 (see (b)(4)) and (b)(6) 2018.It was reported that because a dog jumped up on the patient they think their device had moved because it will not connect.The patient stated that they were able to connect with their device up until a month ago now.It was reported that the issue of the ins not connecting began in (b)(6) 2018 which was also when the dog jumped on them.The patient reported that it stopped charging completely in (b)(6) 2019.They were redirected to follow-up with their healthcare provider (hcp).No further complications were reported/anticipated.

• Brand Name: RESTORE SENSOR
• 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: 8362744
• MDR Text Key: 138906383
• Report Number: 3004209178-2019-03810
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: 02/22/2019

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: 02/14/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 02/22/2019
• Date Device Manufactured: 03/20/2015
• 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: 65 YR