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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the patient¿s friend/family member and the patient regarding the patient with an implantable neurostimulator (ins) spinal pain.It was reported that they were trying to get the check box from group a to group b.The patient right now was on a, they think at 4.70 volts and the patient only felt the stimulation in their legs when they put their head back.They stated as long as the patient was sitting or laying down they felt fine, but if they stood up or walked they felt the pain that they had before they had the implant.They stated they couldn¿t stand long enough to wash the silverware.It was reported that prior to the call the patient was on group a at 4.30 volts and they increased the stimulation to 4.70 volts.On the call they used their programmer to communicate with the ins and it showed that stimulation was on, on group a, program 1 at 4.70 volts and program 2 at 4.30 volts.It was reviewed to consider increasing amplitudes if medically appropriate or change programs.Patient services walked the caller through switching the group to b program 1 and the patient increased stimulation to 3.70 volts and felt stimulation in their stomach.Program 2 was at 2.20 volts and increased to 3.30 volts and felt it in their waist.The patient stated that was not covering the area they needed.The patient switched back to group a, program 1 at 4.70 volts and felt stimulation in their legs when they held their head back.Program 2 was at 4.30 volts and increased to 4.70 volts and the patient could feel stimulation in their back and legs and the patient stated it was good.The caller was told if this didn¿t resolve the call they could follow-up with their doctor or call them back and they could help them adjust it again.The patient stated it was getting worse.The event began (b)(6) 2018.No further complications were reported/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: 7639189
• MDR Text Key: 112447955
• Report Number: 3004209178-2018-14390
• 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: Other
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2018
• Date Device Manufactured: 12/07/2017
• 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: 89 YR