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

Model Number 97713

Device Problems Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Charging Problem (2892); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Depression (2361); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Weight Changes (2607)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported via manufacturer representative that they were getting a recurring power on reset (por) message on their programmer, despite having kept the device charged since implant.No environmental/external factors were report that may have led to the iss ue.The patient was scheduled to meet with a manufacturer representative on wednesday, (b)(6), for troubleshooting.No patient symptoms were reported.Additional information reported that therapy had stopped due to the por.The patient reported that their patient programmer never worked since (b)(6) 2016, and that it always showed a warning por message on the screen since implant.The patient reported they met with manufacturer representative in (b)(6) 2016 and he programmed the device.The patient reported that they had been told over the phone how to do a physician mode recharge several times.The patient stated the warning por came on again 2 weeks prior to report.It was reviewed that the por could not be cleared and needed to be cleared at healthcare provider¿s office.The indication for implant was spinal pain.Additional information was received from the patient and representative.It was reported that after implantable neurostimulator (ins) replacement in (b)(6) 2016, the patient did not use stimulation right away as they were swollen and did not want to use it.However, when they went to use the device, it did not work at first, but then they were reprogrammed by manufacturer representative.They saw a power on reset (por) at some point, used the device for approximately 7 to 10 days, saw the por again and it was cleared around the end of (b)(6).Patient stated the device worked another 7-10 days, a por occurred and patient was seen in (b)(6) to clear por/reprogram.The device worked another 7-10 days and another por occurred.The patient has had a total of 4-5 pors since replacement.Caller states every time the patient is reprogrammed or ins is activated after a por, 7-10 days later another por occurs.It was reported that the device has never gone into overdischarge.Patient indicated they worked with a manufacturer representative to do a jump start at one point and they were able to get device working but the other 2-3 times the patient had to see the representative in person to have por cleared.The patient has not been exposed to emi, except that the patient gets allergy shots.The representative was able to clear the por on the date of the call.They cleared and interrogated the ins, saw 0x80 codes, cleared the por, and restored therapy.While on the call, the patient felt stimulation turn off, checked the ins with patient programmer which showed por.The ins was read with the clinician programmer again and it showed a 0 x 80 code seic reset code.Technical services reviewed to continue clearing the pors with either the patient programmer or clinician programmer as appropriate and they would reach out to the engineers for further information.No patient symptoms were reported.Additional information was received indicating that it was recommended that the device be replaced as the chip that sends the stimulation pulses was constantly being reset.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a representative on 2017-03-10 reporting that there were no actions planned at the moment.It was stated that the device would likely be replaced in the next couple of months.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2017-may-01.The rep stated that the device would not charge and indicated that the event date was (b)(6) 2017.The implantable neurostimulator (ins) was returned for analysis.No further complications were reported/are 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.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found that a capacitor was loose of the circuit board (see notes below).Destructive analysis determined there was a detached tantalum capacitor on the hybrid circuit board of the implantable neurostimulator (ins).The ins passed the final functional test on the automated test console.Additional destructive analysis completed at medtronic hybrid product analysis lab in (b)(4), {sem fractography analysis of the detached xt095 capacitor (c10) and the corresponding hybrid pad surfaces revealed a mostly interfacial fracture mode.} {}.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs referenced to the {referencing the #0 and #8 electrodes} electrode.{loose component in the ins} analysis determined the telemetry was acceptable.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 a legal representative of the patient.It was reported that by december the battery was not working.The patient first informed the company representative (rep), who programmed the battery, that it was not working.The patient was told that the battery had locked up and was told a way to restart the battery.The patient followed the instructions to restart the battery, which did not work.The patient met with a rep who also performed the steps to unlock the battery, the battery remained locked up.The patient then met up with a different rep who performed the steps to unlock the battery, however, it remained unlocked for only five minutes.The battery was defective and it was concluded that there was a faulty sensor in the device that was triggering an error message and replacement was recommended.The patient suffered significant pain and inconveniences associated with the malfunctioning/faulty battery and subsequent surgery.After the ins was implanted, the patient was not able to carry more than ten pounds, and was heavily restricted in lifting and bending as they recovered from implant surgery.The patient unhealthily lost 24lbs, often unable to sleep at night which permeated into every aspect of the patient¿s life.Further stated that unable to rest properly affected the patient¿s ability to perform at work, enjoy activities, and engage with family/friends.The patient was unable to go to the gym or do yoga, and was in contact pain until the battery was replaced.The patient had limited mobility.The patient was unable to walk their dogs, do laundry, change sheets, sit for long periods of time, eat properly, clean the pool, swim, or take care of their yard.The patient must cross and re-cross legs every few minutes and can¿t bend over.The patient was seriously injured, suffered extreme pain and discomfort, and had life altering affects on their life as a result of the defective battery.The patient experienced mental injuries, anguish, anxiety, depression, and sheer emotional distress.The surgery necessary to replace the ins was a traumatic event that left permanent impairment to the patient¿s health and wellbeing.The patient continued to feel less of a person and a shell of their former self.The patient¿s past medical history included: traumatic injury to nerves in lower back and nerve damage.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6395118
• MDR Text Key: 69746224
• Report Number: 3004209178-2017-05403
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2016
• 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 Outcome(s): Required Intervention; Disability
• Patient Age: 49 YR