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

Model Number 97714

Device Problems Failure to Interrogate (1332); Unexpected Therapeutic Results (1631); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/09/2016

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 manufacturer representative regarding a patient who was implanted with a neurostimulator for failed back surgery syndrome and spinal pain.The manufacturer representative reported that per the patient they were not feeling like they were getting as good of pain relief as they had during the trial.The manufacturer representative noted that they were planning on adjusting the system.¿the patient was a secondary caller on the phone and the patient¿s employment and considerations regarding electromagnetic interference (emi).¿ the manufacturer representative worked in an environment with strong emi.The patient was encouraged during the call to speak with their safety officer at their work.On 2018-jun-18 additional information was received from a consumer regarding the patient.It was reported that the patient got the device to get rid of some numbness and pain they had following a back surgery.The implanted device was not doing its job; it never stopped the numbness like the trial device did so the patient stopped charging their implant.It was noted the patient did charge their device 6 months prior to the report (around the end of 2017 or beginning of 2018), but the patient has not tried to charge since then.They were redirected to the doctor to determine if the device was in overdischarge.No further complications were reported or anticipated.More information received 2018-jun-21 with patient reporting their unit will charge but that they were getting the power on reset (por) when trying to turn it on.They were told that the device needed to be interrogated.Patient wanted to see if they could arrange a meeting with a manufacturer representative (rep) at their healthcare professional (hcp) office because it would not turn on.Patient stated they wanted to put it in mri mode for an unrelated mri of their hip.It was noted that the por was related to an overdischarge event.They weren't using the device anymore for 5-6 months because it wasn't doing anything for their numbness.So the device had been off or dead.No further complications were reported.[omitted information pertaining to the new hip issue / pain - see pe#: (b)(4)].

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported that he called a manufacturer¿s representative (rep).The patient reported that he tried to charge last night numerous times as the rep told him to after he called but his device just wouldn¿t sync and guessed the device would need to be jumpstarted.The patient reported that he was just trying to get an mri.The patient reported that they told him the device would work but it¿s not working had never performed.No further complications were reported.[omitted information pertaining to the new hip issue / pain - see pe# (b)(4)].

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported that it was confirmed by a manufacturer¿s representative (rep) that the neurostimulator (ins) was in overdischarge.The patient reported that the doctor wasn't able to determine the cause of the ins not being as effective as the trial.The patient reported that no further steps will be taken.The patient reported that a rep said there was nothing else he could do or that the patient could have it removed at ¿my expense.¿ no further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the patient indicated that a manufacturing representative (rep) assisted in resetting their device, which resolved the por and overdischarge.No further complications were reported or anticipated.

• 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: 7635679
• MDR Text Key: 112596102
• Report Number: 3004209178-2018-14277
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2018
• Date Device Manufactured: 08/12/2016
• 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: 58 YR
• Patient Weight: 132