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

Model Number 97714

Device Problems Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 12/17/2017

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 patient with an implantable neurostimulator (ins) for spinal pain.The patient stated that their ot her settings were not helping.The effects of the settings changed due to being hospitalized for a lower back injury that made them bed ridden.This began probably about a month prior to (b)(6) 2018.The ins was to help with their lower back injury.People were yanking and tugging at them when they were hospitalized.They are not bed ridden anymore.The rep was told about their issues with the settings about a month prior to (b)(6) 2018.The rep adjusted the settings but the patient tried changing the settings back by adjusting the ¿velocity¿ because after several hours and the recharger being fully charged the ins is not charging fully and it has to be charged every other day.It used to have to charge every 3 days.The rep put the ins on cycling mode so it is being used more frequently than it was before and there are increased parameters.The ins gets to about 75% and blinks for like an hour but it won¿t ever get to the charge sufficient screen.That is why the patient re-adjusted the settings on the ins and thought they went back to the old settings.The patient stated that it won¿t get to 100% recently.This began about 3 weeks ago.The patient was redirected to follow up with their healthcare professional (hcp).No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient was instructed to do log recharging and obtain recharging statistics.It was reported that troubleshooting resolved the reported issue.It was reviewed recharging icon on 100% vs 90% full quartile on recharger, reviewed recharging statistic shows patient has been charging up to 90% full, not 100%.The caller reported the patient's daughter has confirmed 90% icon on recharge.The caller confirmed, no allegation against device/therapy, and the caller confirmed the recharging issue was educational and the issue had been resolved.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 consumer.The consumer reported that there wasn¿t a device issue, they were increasing the power in program 2 and it was taking longer and longer to charge the unit and it had to be charged daily.The consumer reported that the patient was hospitalized for a bladder infection.The consumer reported that the cause of the neurostimulator (ins) not fully charging was not determined.The consumer reported that a manufacturer¿s representative (rep) told them that it was normal for it to be charged daily with this program.The consumer reported that it was still not charging fully and no interventions were taken to resolve the issue.The issue wasn¿t resolved.The consumer reported that the patient had spinal stenosis in the lower back in the lumbar area and also sciatica.Additional information was received from a manufacturer¿s representative (rep) on 2018-02-21.The rep reported that the patient was seeing ¿weird¿ things on their recharger.The rep also reported that the patient was charging more frequently and it was taking extra time to charge.The rep reported that the patient would start charging at 50% per the recharger and then after 30 minutes the ins would be full (charge complete screen on the recharger).The rep reported that the patient came into the office at 50%, started charging and after 30-40 minutes, the recharger showed full which didn¿t seem right to the patient.The rep reported that the patient then reconnected with the recharger and they had been charging for 2 hours and the last quartile had been blinking.The rep reported that it appeared the charge levels matched on the patient programmer (pp) and recharger.The rep reported that the patient was in the hospital in december 2017 for an unrelated surgery and the patient had to lay on her side on a gurney for a long period of time and was in so much pain by the time they went to surgery, they were crying and the patient had been on narco and dilaudid.The rep reported that another rep came to the hospital and they tried all 4 programs, but ultimately ended up using the same program that the patient had been on but just at a higher voltage.The rep reported that they had been at 5.27v, but this was increased to 7.0v and the rep reviewed that this would cause an increase in recharging.The rep reported that they used their personal recharger on the ins and it showed 8 bars and that the last quartile was blinking, similar to what the patient was seeing with their recharger.Recharge statistics were obtained and showed the following: charge level - full, service life - ok typical duration - 2 hours typical interval (days) - 0.7 typical coupling - 4 (b)(6) - 2.6 hours, 100% charged (b)(6) - 1.7 hours, 100% charged (b)(6) - 3.6 hours, 100% charged (b)(6) - 2.0 hours, 75% charged (b)(6) - 0.0 hours, 75% charged 2/17 - 1.8 hours, 75% charged it was suggested that the patient keep a diary of the ins charge level on the pp and recharger when they start charging, end charging, how long they charge and what coupling was and then come back and have the recharger statistics gathered again.No further complications were 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: 7261946
• MDR Text Key: 99998796
• Report Number: 3004209178-2018-03067
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2018
• Date Device Manufactured: 01/30/2014
• 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: 92 YR
• Patient Weight: 53