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

Model Number 97714

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Charging Problem (2892); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Fall (1848); Device Overstimulation of Tissue (1991); Pain (1994); Sprain (2083); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Injury (2348); Ambulation Difficulties (2544)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a healthcare professional regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient will be walking and all of a sudden their stimulation while speed up by itself.It was noted that the patient fell on (b)(6) 2018.The patient's hcp noted that the machine started 'going crazy' and had caused the patient to fall.Follow-up was conducted.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that they noticed that the stimulation seemed to be adjusting on its own over the past two and a half days.The patient confirmed that they had adaptive stimulation (as) active but stated that this was something new that had just started.The patient mentioned that they fell on (b)(6) 2018.The patient stated that the reason they fell was because of the strong stimulation in their legs and that they had no falls prior to that.The patient further reported that the device was ¿going crazy¿ and that there was something wrong with it, as it would speed up on its own while they were walking.The patient noted that the device was still going on high speed and that they had fallen twice in two days because of that.It was also reported that the patient skinned up their left leg and had a cut down by their ankle from falling.No further com plications were reported or anticipated.

Manufacturer Narrative

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 was received from the patient.It was reported that the patient had now fallen three times and hadn¿t made an appointment yet to have the device checked.The patient stated that the machine would go crazy, speed up, and vibrate them.The patient lost their balance, cut their left ankle, and twisted their right ankle.The patient stated that it was getting black and blue, and that it hurts.The patient was trying to contact the manufacturer because the equipment was malfunctioning in their body.It was further reported on (b)(6) 2018 that the patient ordered adhesive discs.However, they called back three days later stating that they hadn¿t received them yet and really needed them so that they could charge their implantable neurostimulator (ins).No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the machine messed them up and they were still waiting for adhesive pads.The patient stated that their ankle still hurt from when they fell on (b)(6) 2018.The patient mentioned that they were going to be in a lot pain all weekend.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer.The patient used to clear carpet and work tile which screwed up their back.The patient was reported to have heart disease.It was reported that the device was going crazy.The patient had fallen and got hurt.The patient had to go to the hospital on the day of the report because their ankle was still black and blue.The patient was in pain on the day of the report ((b)(6) 2018) because they could not charge due to the patient not getting their order of adhesive discs.It was noted that the patient's charger died on (b)(6) 2018.The caller stated that the machine malfunctioned on (b)(6), acted weird, and the patient turned it down.The patient was walking when the device went crazy, sped up, and they had to go to the hospital after they fell.The manufacturer representative reprogrammed the device 6 days later.Per the caller, the manufacturer representative stated the leads were fine but the program was malfunctioning x-rays were performed on their severely sprained ankle.The patient was provided muscle relaxers and anti-inflammatory medication.It was reported that the patient fell twice.The second tim e was in shower on monday.When the patient moved, the device sped up to maximum so that the patient had to lower it.This kept occurring until it was resolved with the programming on (b)(6) 2018.It was confirmed by patient services that the adhesive discs were delivered on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7801415
• MDR Text Key: 118269058
• Report Number: 3004209178-2018-18738
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Date Device Manufactured: 09/18/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 56 YR