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

Model Number 97702

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)

Event Date 10/22/1997

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 7425, serial#: (b)(4), implanted: (b)(6) 2000, product type: implantable neurostimulator, product id: 7425, serial#: (b)(4), implanted: (b)(6) 1997, product type: implantable neurostimulator, product id: 37702, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 7427, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2010, product type: implantable neurostimulator.Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type: lead.Product id: 3587a, lot#: n089414, implanted: (b)(6) 2008, explanted: (b)(6) 2010, product type: lead.Product id: 3587a, lot#: l84957, implanted: (b)(6) 2000, product type: lead.Product id: 3587a, lot#: l46612, implanted: (b)(6) 1997, product type: lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 28-feb-2016, udi#: (b)(4); product id: 39565-65, serial/lot #: (b)(4), ubd: 07-dec-2013, udi#: (b)(4); product id: 3587a, serial/lot #: (b)(4), ubd: 30-oct-2010, udi#: (b)(4) ; product id: 3587a, serial/lot #: (b)(4), ubd: 18-sep-2004, udi#: (b)(4) ; product id: 3587a, serial/lot #: (b)(4), ubd: 18-sep-2004, 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) for non-malignant pain, degenerative disc disease, rsd/causalgia ¿ complex regional pain syndrome and other chronic/intract pain (trunk/limbs).The patient reported that she hadn¿t been able to lay down all night because stimulation was close to her spine when she laid down and she couldn¿t sleep that way.Additional information was received from the patient on 2018-05-23.The patient reported that when she laid down, stimulation went crazy.Additional information was received from the patient on 2019-12-17.The patient reported that with every ins she has had since initial date of implant, when she laid down, stimulation goes crazy and the stimulation goes ¿up and down legs.¿ the patient reported that due to this she had to turn off stimulation when she laid down and then she would forget to turn stimulation back on and then she would be in pain.The patient reported that this had occurred with every implant since initial date of implant.The patient reported that she thought this was normal and that when she laid down she thought the lead got closer to her spine and that was why this occurred.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: 9559257
• MDR Text Key: 175420501
• Report Number: 3004209178-2020-00356
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Date Device Manufactured: 01/23/2014
• 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
• Patient Age: 40 YR