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

Model Number 97714

Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problems Headache (1880); Undesired Nerve Stimulation (1980); Tinnitus (2103); Blurred Vision (2137); Tingling (2171); Electric Shock (2554)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial#: (b)(4) ,implanted: (b)(6) 2016, product type: implantable neurostimulator.Mdr # 3004209178-2018-20550 addresses the patient's other implanted scs system.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 a neurostimulator for complex reg pain syndrome type ii, spinal pain, and non-malignant pain.The consumer had 2 implanted systems one for cervical spine and the other for thoracic spine.It was reported that the device had been badly shocking the patient.It was reported to be some kind of change in the cabling or frequencies inside their hose that was shocking the patient from their brain stem down to their feet which caused headaches, blurred visions, tinnitus/tingling in their ear, and shocking in every limb and their bowels and everywhere.The consumer believed that both scs systems were shocking the patient.Both of the devices were off.The patient let one device go head and the other was turned off.Both were shocking the patient.It was reported that they did not know if the device was malfunctioning or what was going on.There were no reported falls, emi, traumas, or activities affecting the systems.It was stated that the patient had contractors from the cable company put in some signal boosters in the coaxial cables around the house.The patient had a "ampersound detector" that picked up electrical and radio frequencies that showed up to 6 to 30 hz every time their air conditioner comes on or there is a thunderstorm.The patient got a shock when those events occurred.It was reported that even the static electricity in the air would transfer to their implant and shock the patient.This had been occurring the past 3 to 4 weeks starting in (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information from the health care provider (hcp) noted that no actions were taken and the patient would not be having these issues corrected.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.It was reported that the patient was notified that they needed their battery changed.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) and consumer (con).The rep reported that the patient was seen in the hospital by a rep on (b)(6) 2018.Patient services asked if this was at all related to the implant.The rep asked the patient who was with her during the time of the call, and reported that the patient was in there because the ins for the patient¿s arm and upper body was currently off, but the patient was still getting a "shocking feeling".Patient services asked a date for when this issue occurred.The rep answered "let¿s say (b)(6)".The rep reported that the patient had x-rays done to look at the placement and the placement was fine, but the impedances "were all out on the top stimulator" and she couldn't get to the bottom stimulator.The patient noted this was around (b)(6) when the rep was notified of this issue as well.Additional in formation was received from the manufacturer representative (rep) on october 24th.The rep reported that in reference to the patient being in the hospital, it was not due to the device/therapy, and was due to the patient having uncontrolled cprs.The rep stated that the patient was seen on (b)(6), and not (b)(6).The rep reported that the cause of shocking was not determined, and that the actions taken to resolve the shocking where that the x-ray was conducted and both devices are off.The rep clarified the statement ¿impedances were all out on the top stimulator¿ to mean that impedances were >20,000.The serial number of the ¿top stimulator¿ was not known.The rep reported that the cause of the impedances being >20,000 was not known.The action taken to resolve the impedances being >20,000 was that the stimulator was turned off.No further complications were anticipated/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: 7872808
• MDR Text Key: 123730867
• Report Number: 3004209178-2018-20552
• 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,Followup,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Date Device Manufactured: 02/15/2017
• 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: 35 YR