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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient (pt) reported that they're considering having their implant removed mostly due to the fact that their spine condition is worsening.Pt stated they use the therapy on and off and since they were implanted and sometimes it would provide relief and sometimes it wouldn't.Pt reported that since implant if they used therapy while driving or while laying down it would give them a "jolt" of unexpected stimulation that pt described as going from their feet to their brain. pt stated that sometime around (b)(6) 2021 they noticed the battery was depleting faster.Pt reported that about 2-2.5 weeks later, their implant would not longer charge.Pt is already working with their physician to decide whether or not they will have the device explanted.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 11931210
• MDR Text Key: 254054487
• Report Number: 3004209178-2021-08787
• 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: 06/03/2021

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: 02/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/03/2021
• Date Device Manufactured: 03/30/2016
• 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 Age: 56 YR