MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427

Device Problems Break (1069); Failure to Deliver Energy (1211); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for multiple back operations.It was reported that there was no stimulation.This was unrelated to a fall, trauma, or electromagnetic interference (emi).The patient checked the patient programmer and it showed stimulation was on.During the call the patient was able to decrease however when the patient increased they heard 3 beeps.The meaning of this beeping signal was reviewed to mean that the patient had reached the maximum range set by the physician.The patient was referred to their physician.The patient did not have another group to try.The patient had not seen their original managing health care professional (hcp) in 13 years and did not have a managing hcp.The patient had an appointment with their primary care physician for (b)(6) 2017.It was noted that the patient had their device due to a settlement and therefore the patient may need to contact their lawyer in order to be directed to the appropriate physician.The loss of stim ulation started about a week ago in (b)(6) 2017.Additional information was received from the patient.It was reported that the patient forgot to mention the loss of stimulation to their health care provider and that the loss of stimulation had not been resolved.Additional information was received from the patient.It was reported that the patient turned on the stimulator and it was not working like it normally was when they first got it; the patient further explained that they could barely feel anything, then clarified that they were not feeling any stimulation.The patient reported that they tried increasing the stimulation, but it will not do anything.The patient reported that it beeps when they increase the stimulation and it will not go.The patient corrected what they reported earlier and stated that they could feel stimulation in right in the front on the side of the vagina.The patient noted that their back was bothering about 5 days before the call.The patient stated that they used to be able to feel it all the way down their legs and across part of their back.The patient noted that they have to turn the stimulation all the way up to feel anything at all.No further complications are anticipated.Additional information as received from the manufacturing representative (rep) reporting that they were checking the patient¿s battery because they were considering replacing the ins.It was reported that they check the patient¿s impedances and were seeing question marks (???) on some pairs of electrodes.It was reported that the rep was with the patient and/or the healthcare provider (hcp) at the time of the call to do further troubleshooting.Technical services reviewed increasing the amplitude to 3 v and to rerun the impedances.The rep state that they were still see the question marks (???) for some results.They then reran the impedances again at 4 v.The caller relayed the following impedance results: 02: ??? 12: 1893 ohms 01, 03,04, 04, 06, 07, 24, 25, 26, 27 were all 3762 ohms the rep stated that they programmed 1+ 2+ 3- and were able to get stimulation in the patient¿s legs, but the patient needed it in their back and legs.Technical services reviewed impedance information and the rep stated that they would work on programming options with the patient to determine if the leads need to be replaced when/if they choose to change the ins out.No symptoms were reported.It was indicated that the rep was the one to discover the elevated impedances on the day of the report, (b)(6) 2017.It was indicated that the patient does not have an hcp.No further complications were reported/anticipated.Additional information was received from the manufacturer representative on 2017-10-25.It was reported that they tried increasing the parameters for impedance check to get more accurate results.Per tech support, electrodes 0 and 2 were not working properly and to avoid those.The patient has decided she would like the system replaced and was going to make an appointment with their healthcare provider for further evaluation.No further complications were reported.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6995113
• MDR Text Key: 91449370
• Report Number: 1030489-2017-02276
• 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
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2005
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2017
• Date Device Manufactured: 07/29/2003
• 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 Age: 54 YR