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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Depression (2361)

Event Date 11/17/2016

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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that when the patient bends their stimulation increases and made them jump and fall down all the time.They felt like a bee stung them in the back when leaning against a chair even with the stimulator off.The implant was located by their belt and they didn't like where the implant is positioned.The patient was implanted for neuropathy in their feet and above their ankle/lower legs but it didn't do anything for their neck and shoulders where the patient had more nerve damage.They used to received hydrocodone to deal with the pain but once the stimulator was implanted the doctor took away their medication.The patient has since been receiving only half the relief and it was miserable.They reported that it took 2 hours to get to the doctor's office and the patient comes home and was miserable; they were depressed and laying around.They reported they would discuss having their implant removed with their doctor.No further complications reported.

Manufacturer Narrative

Device c63043 no longer applies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information from the consumer regarding a patient on (b)(6) reported the circumstances that led to the increase when bending was it was always changing on them.The patient noted they could not afford to go to the healthcare professional¿s (hcp) office.The patient stated the step taken to resolve the increase in stimulation when bending was they turned it off.There were no further complications that have been reported as a result of this event.

• 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: 7480547
• MDR Text Key: 107211588
• Report Number: 3004209178-2018-09889
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

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: 09/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 05/18/2018
• Supplement Dates FDA Received: 05/18/2018; 05/18/2018
• Date Device Manufactured: 10/27/2016
• 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: 47 YR
• Patient Weight: 95