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

Model Number 97714

Device Problems Disconnection (1171); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Material Deformation (2976)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 06/30/2016

Event Type  Injury  

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

The consumer via the manufacturer representative reported that there was a loss of stimulation in the patient¿s right foot on (b)(6) 2016; it was noted that the implantable neurostimulator (ins) was implanted for pain the patient¿s right foot and leg.While the patient was still at home, increasing stimulation using the patient programmer did not resolve the loss of stimulation and created jolting sensations.There were no falls or trauma associated with the issue.The patient reported a fall in (b)(6) 2016 and a recent foot surgery that took place over a month ago (exact timing was unknown).The patient stated the loss of stimulation was during a recent vacation, and the foot surgery and fall did not occur near the time of stimulation loss.The manufacturer representative reprogrammed the patient on (b)(6) 2016, and the patient was able to re-establish stimulation.It was noted that the patient was getting good stimulation.Additional information received from the consumer on 14-jul-2016 reported that when the patient met with the manufacturer representative on (b)(6) 2016, the manufacturer representative ran a test and told the patient that 5 of the 8 electrodes were out-of-range.It was noted that the patient had met with the manufacturer representative only, not the healthcare professional.There were no falls or trauma associated that could be related to the issue; the patient stated she did not have any falls, trauma, or a change in activity.The patient stated she was going to see the healthcare professional the week after (b)(6) 2016 to discuss next steps and possible surgery.The patient stated that she knew she was going to have surgery; the patient mentioned she was concerned about the lead being covered under warranty.The patient was concerned that with the surgery schedule and her family life, she would not be able to have the surgery and have the lead sent back within a year.The patient¿s indications for use included non-malignant pain and complex reg pain syndrome type i.

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 the patient and manufacturer representative reporting that the manufacturer representative met with the patient and reprogrammed the scs system.The patient was able to get leg coverage with the remaining electrodes that were in range.The cause of the loss of stimulation, shocking, and oor impedances remains undetermined.There was no further information regarding the fall and the foot surgery.

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.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 received from the consumer on 02-aug-2016 reported that the patient spoke with manufacturer representatives on (b)(6) 2016 for troubleshooting regarding the loss of leg stimulation on (b)(6) 2016.The patient was instructed to try a few things with the patient programmer; during one of the things she had tried with the patient programmer, the patient felt a jolt in the right buttock that felt as though she got kicked in the butt.The patient denied any falls or trauma related to the shocking sensation; she stated that she was just living her life and she was not on activity restriction.After the manufacturer representative reprogrammed around the 5 out-of-range electrodes discovered on (b)(6) 2016, the patient asked the manufacturer representative to speak with the healthcare professional and review next steps.The patient did not hear back from the manufacturer representative, and then reached out to the healthcare professional.The patient met with the healthcare professional on (b)(6) 2016 and x-rays were taken to determine whether there were any micro-fractures on the electrodes.The x-rays showed no micro-fractures, however the lead was coiled up.It was noted that the patient was experiencing pain in her back, and the healthcare professional stated that the coiled up lead could be the cause.The healthcare professional reviewed that the patient could have a replacement; the patient would need to have labs, x-rays, and an electrocardiogram (ekg) or have the system removed.The patient reported that the orthopedic surgeon stated that it was up to her but she could turn the device off to see how her pain level was.The patient had her system off for a few weeks and she was in pain, but she was more afraid of going through lab work and device replacement.It was noted that the patient had had 3 surgeries in the last 2 years and she did not feel as though she could hand another one know it could happen again.It was reviewed that if the patient had device replacement/explant, the patient¿s unreimbursed medical would be reviewed as a gesture of goodwill and the device would need to be sent back.The patient further stated that she would follow up when her surgery was scheduled; she will most likely wait until (b)(6).It was noted that her insurance would change on (b)(6) 2016, and she wanted the surgery done by then.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported lead migration had been discovered on x-rays in the same month as the out of range impedances.The consumer additionally reported they had the entire system explanted on (b)(6) 2016; the system wasn't replaced.

Manufacturer Narrative

Device returned and evaluated.Product analysis #701404860:the ins was received with no telemetry.According to the trace report obtained from the ins after pmr recovery, the total recharge count is 59.The last recorded recharge session performed while the device was implanted occurred on (b)(6) 2016.The device was recharged for 41 minutes and the battery charged from 3.72v to 3.80v.The battery discharged to the lock mode on (b)(6) 2016.The parameter trend diagnostic section of the trace report shows the last patient usage was on (b)(6) 2016.Information references the main component of the system and other applicable components are:product id 97792, product type: accessory.Product id: 3550-29, product type: accessory.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type lead.

Event Description

Device returned and evaluated.

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.

Manufacturer Narrative

Analysis of the lead with serial number (b)(4) found that all wires at the anchor site were broken 22.4 centimeters from the distal end.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.

Manufacturer Narrative

Evaluation result code 1 does not apply.Evaluation conclusion code does not apply.Evaluation conclusion code does not apply.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 consumer regarding the patient.It was reported that 3 of the 8 leads came ¿unplugged¿ and she was being shocked starting in (b)(6) of 2016 which was the reason for explant in (b)(6) of 2016.No further complications were reported or anticipated.

Manufacturer Narrative

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

• 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: 5820619
• MDR Text Key: 50387666
• Report Number: 3004209178-2016-14902
• Device Sequence Number: 1
• Product Code: GZB
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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
• Patient Age: 33 YR
• Patient Weight: 77