MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3531
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Pain (1994); Urinary Retention (2119); Discomfort (2330); Numbness (2415)
Date of Event	10/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the manufacturer¿s representative regarding a trial patient who was implanted for advance evaluation (ae).It was reported that the trial patient was in the emergency room (er) and stated that ¿something went terribly wrong with device¿.The trial started on (b)(6) 2017 for fecal incontinence.It was noted that there was good lead placement at s3.The patient experienced terrible pain and was in agony.They decreased the stimulation but still had the pain.The device was shut off and when the patient tried turning it back on but was in too much pain and both of their legs were numb.The patient was currently at the hospital and was given pain medication.On (b)(6) 2017, it was reported the patient met with their doctor where the program was changed from 1 to 3 and a new external neurostimulator (ens) was used.It was noted that the pain from yesterday had subsided but they were still very sore.The patient stated that they were unable to urinate on their own yesterday and had to be catheterized while at the hospital.However, today the patient was able to void on their own.Additional information from the manufacturer¿s representative received on (b)(6) 2017 reported the patient was getting good symptom control but had bilateral pelvic pain that gradually increased to the legs bilaterally.The patient¿s bladder was not emptying.It was noted that post-implant the patient did not take any pain medications.The representative did not feel the pain was related to procedural pain.It was confirmed the patient had severe pain on saturday and the stimulation was turned off saturday morning.The pain got better so the stimulation was turned back on saturday evening.The patient then had severe pain on sunday ((b)(6) 2017) and went to the er.The patient was seen by the nurse on (b)(6) 2017 for the severe pain where it was determined the device was set at 0.0 ma but the green light was on.The nurse unplugged the cable which resolved the pain.The nurse also switched out the ens and the pain resolved in the doctor¿s office.The patient was sent home but when they got home the pain continued.On the morning of (b)(6) 2017 it was reported the patient was in a lot of pain.Per the physician, the site looked fine with no signs of infection.There were no falls or trauma reported that could be related to the issue.Again, it was reported the patient was getting good symptom relief.It was later reported that patient felt uncomfortable stimulation in the vaginal area.The electrodes were reprogrammed and the amplitude was lowered and the patient felt ¿ok¿ again.The nurse did note the patient felt pain in the buttocks area where they sat but did not feel that sensation now.An x-ray was performed and showed the leads were still in the correct location.It was reported that patient¿s pain seemed resolved now and they were going to go home and continue the trial evaluation.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reiterated that the patient¿s pain and discomfort did not subside with the new ens so it was assumed that it was not caused by the ens.Additionally, it was reported that the patient informed the nursing staff that they were in a car accident just before the trial started that may have contributed to their pain.No further patient complications are anticipated or expected as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a healthcare provider (hcp) stating that the patient went through the advanced evaluation 11 days ((b)(6) 2017) before their visit (on (b)(6) 2017) and noted being in the emergency room over the weekend before due to post-op persistent sacral pain.The patient was at the visit to follow up on the discomfort and problems voiding they were having the weekend before.While they were in the emergency room it was discovered that their bladder was full, but no other problems were noted.The patient reported constant pain when sitting bilaterally at the ischial tuberosity and radiating pain down both legs.The dressing and incisions were intact with no signs of redness, swelling, or drainage.It was noted that the exam was otherwise unremarkable.The imaging, both regular x-rays, and ct showed no complications or movement of the lead.It was reported that the symptoms would improve with the device off, however they did not go away, which was why she went in to the doctor and why they went to the emergency room the day before.The hcp found out that the patient went down to 0.0 volts on program 1 but did not have the device completely off.Examination of the patient¿s lower back and buttock showed that everything looked well healed without signs of infection.It was reported that the hcp felt that it was related to the external neurostimulator (ens) so they gave them a new ens.It was noted that when they disconnected the ens the pain was instantly improved.It was reported that they were able to turn it on and had no discomfort, was able to walk without difficulty and void a moderate amount of urine within minutes.The patient was changed to program 4 to avoid urinary retention, which seemed like they were getting from the original program that they had been on.It was noted that the evaluation was successful in treating their fecal incontinence.It was noted that the patient was successfully implanted on (b)(6) 2017.The hcp also reported that the discomfort was determined not to be related, which contradicts previously reported information.It was reported that the urinary issues had since been resolved.No further complications were reported.

• Brand Name: VERIFY
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 6987145
• Report Number: 3004593495-2017-00642
• Device Sequence Number: 1091012
• Product Code: EZW
• UDI-Device Identifier: 00643169725072
• UDI-Public: 00643169725072
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2017
• Supplement Date Received by Manufacturer: 10/08/2017; 12/19/2017; 12/21/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 10/30/2017; 12/21/2017; 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 52