MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a260, serial#: (b)(4), product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 25-oct-2017, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 25-oct-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the leads were left implanted but the stimulator was removed.Pt stated the therapy worked okay at first but had to be set really high so the charge didn't last long.Pt stated they met with a mdt rep who adjusted the therapy a bunch of times but could never get great relief.Patient stated it didn't work.Pt stated they had the stimulator removed and a year or two later they discovered the leads were still implanted when they had a chest x-ray at a physical.Pt stated the lead was "wavy" and 4-5 mins from the spine so they think that may be why the therapy didn't really work.Pt mentioned no falls/trauma.Pt stated they have a fused vertebrae and sleeping was painful.Pt mentioned they reported this removal to the previous agent (prs)that they spoke with before patient services.Pt mentioned the ins was removed but the leads remain implanted.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 12043268
• MDR Text Key: 257494818
• Report Number: 3004209178-2021-09765
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Date Device Manufactured: 10/17/2013
• 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