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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 03/09/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 97754, serial# (b)(4), product type: recharger.(b)(4).

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim, gastrointestinal/pelvic floor, and interstitial cystitis.It was reported that an overdischarge was alleged.The patient programmer (pp) and implantable neurostimulator recharger (insr) could not communicate with the implantable n neurostimulator (ins).The last successful recharge was in (b)(6) 2015.An antenna locate (al) feature was performed that resulted in the highest number of 78.No symptoms reported.After one physician mode recharge (pmr), nothing would communicate with the ins.It was noted that it was a pain device that was being used to treat urinary issues.It was made sure that they had the right software card in order to clear the power on reset (por).A day later the patient was back and they were performing another pmr.They used the al feature and got up to 80 to confirm placement.The recharge statistics showed that the last recharge session was (b)(6) 2015 with 31.3 max temp, 3 average coupling, 85 hear loss, 30 average temp, session lasted 9 minutes, 3 minutes due to poor telemetry, 3.895 start and 3.895 ending voltage.All other sessions were reading 01-01-00 for date and all zeroes.This showed the last recharging was on (b)(6) 2015.The patient reported charging in (b)(6) and seeing all the black coupling boxes.She felt stimulation in (b)(6) and lost therapeutic benefit in (b)(6).According to her personal journal she last charged on (b)(6) 2016.They were going to continue to perform the pmrs back to back today and see if they could get a response from the device.They would call back if they wanted to send a replacement recharger.Three days later on (b)(6) 2016 a manufacturing representative (rep) reported that they were with the hcp and performed 4 pmrs back to back last week with no success and the ins was still depleted.They wanted to try a replacement recharger.Two days later on (b)(6) 2016 the patient reported that they had spent 4 days in the urologist¿s office trying to ¿jump start¿ the machine but nothing was working.A day later the rep and hcp reported that they had tried another recharger and performed multiple pmrs and then the patient did 2 more immediately.The patient performed one on the drive home and another when she got home.The recharger would still not communicate with the implant.They were going to order an x-ray to determine if the device had flipped.Further follow-up is being conducted to determine what diagnostics, troubleshooting, actions or interventions were performed, and if the issues were resolved.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Note that section d information references the main component of the system and other applicable components are: concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.

Event Description

The patient later reports she have the neurostimulator for interstitial cystitis.It was put in last year and was supposed to be the rechargeable one.The patient had recharged her device on numerous occasions.She reported it was dead.The patient had spent 4 days in urologist office trying to "jump start' the machine but nothing was working.The patient reported difficulty recharging.She was unable to charge.Her device wasn't working.The insr won't find her implant.She wasn't feeling stimulation.They tried to jump start her device 5 days in a row.The p.A.(physician assistant) at the doctor's office was on the phone with manufacturer every time they did the jump start.She did a total of 21 hours of jump starts.An x-ray was done to determine the device was not flipped.Patient said the last time she successfully charged the device was in (b)(6).She charged the device every 3.5-4 months.Symptoms reported were she had a bruise from doing so many jump starts.Patient had bladder spasm.It was unknown when the patient stopped feeling stimulation and unable to charge.Patient insr was replaced in (b)(6) and this did not resolve the issue.The healthcare provider reported to the caller that she was still having problems.The hcp reviewed that according to the diary, it had not been charged appropriately.The patient indicates that she was told this battery would have a 5-10 year life.The manufacturer representative redirected the patient to call patient services.The healthcare provider had not heard back about the x-ray to see if the device was flipped.The caller states that she has not.The patient was requesting compensation alleging her device was defective.The device does not work and it has been decided the device was defective.Additional information reports that the patient said that she didn't receive any education about recharging other than was told to read the book.Patient did recharge the device and it wasn't until (b)(6) 2015 that she received the screen that it wasn't recharging and she stopped feeling stimulation.Prior to that patient did not receive any error messages.Patient said when she tried again in (b)(6) 2016 the recharger couldn't find her ins and patient worked extensively with manufacturer representative and hcp to jump start it, to get it working however the attempts were not successful and patient never received the por screen.Patient also said that she did get the x-ray results and was told that the device was not flipped.She was told that hcp office sent a snapshot of the x-ray to the manufacturer representative.Patient would like to continue with the therapy.Additional information from the patient reports the device was not charged and we cannot get it to charge.The patient need to have it replaced and am wondering if this device was covered under some sort of warranty with regards to not working properly.It was put in (b)(6) 2015 and stopped working in (b)(6) of 2015.

Manufacturer Narrative

Concomitant medical products: product id 3550-29, product type: accessory.Product id 97754, serial# (b)(4), product type: recharger.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 patient later call back to check to see if device was received for analysis.The doctor did a revision on her restore neurostimulator today which was being sent back for analysis due to the quick depletion of the battery.The device was returned with the following information.The battery would not recharge after multiple attempts.New charger sent to doctor but no charge and could not recharge.The patient was alive with no injury at time of report.The patient recovered without sequela.

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 received from the representative reports patient saw doctor's physician assistant (pa) and was unable to recharge her device.They tried several times without success.The pa called on one or two occasions trying to get it to recharge.They was sent a new recharger but after several attempts, it still would not charge.Per the pa, the device had not been charged in several months.Patient admitted that she would only charge it every 2 months or so.The issue resolved at the time of this report.Patient status at time of this report was alive with no injury.

Manufacturer Narrative

Analysis of the stim ins (b)(4) concluded the battery had reduced capacity due to overdischarge.The ins was received with no telemetry.According to the trace report obtained from the ins after pmr recovery, the total recharge count is 4.The last recorded recharge session performed while the device was implanted has the default date of (b)(6) 2000 due to por.The first charge recorded occurred on (b)(6) 2015, lasted for 5 minutes, and the battery voltage remained at 3.895v.The battery discharged to the lock mode on (b)(6) 2015.Testing of the recharge function of this ins found it to be functioning normally.The ins charged with 100% coupling.

Manufacturer Narrative

Corrected information: no eval explain code 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.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5503011
• MDR Text Key: 40589944
• Report Number: 3004209178-2016-04649
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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: 00047 YR