MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3531

Device Problem Human-Device Interface Problem (2949)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Discomfort (2330); Complaint, Ill-Defined (2331); Abdominal Distention (2601)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the manufacturer¿s representative regarding a trial patient who was implanted for basic evaluation (be).It was reported that the trial patient felt pain in their back and spine.They noted they had a pinched nerve and took hydrocodone.Additional information received on oct.28 and 29, 2017 reported the patient was having trouble with the controller while attempting to increase the stimulation.Troubleshooting was performed (details not provided).The patient stated that increasing the stimulation caused pain but wanted to continue to increase it because they wanted it to work fast.They also noted they were not in as much pain since switching sides but reported they had not been seeing much improvement.In addition, the patient reported they had a tumor in their leg and had pain in the tumor from the stimulation.They also mentioned they felt bloated and had bleeding on the bandages.Further the patient stated that the procedure did not go well and the physician thought they may have nerve damage.The patient then changed sides from the left to the right.Follow up information received on oct.30, 2017 reported that since the patient had changed sides, they had been unable to void on their own.The patient also had a tumor on their hip and a pinched nerve so they were unsure where the pain was coming from.They stated that the pain was worse when the catheterized.Further the patient reported that the felt like their pinched nerved was ¿not accepted¿ the stimulation.It was noted that they switched back sides and the patient felt the stimulation in their tailbone at 0.2.Additional information received on oct.31, 2017, reported that the trial patient¿s controller kept turning off on its own.The patient also mentioned that they had been unable to void on their own so the stimulation was raised.They described the stimulation as a ¿pressure¿ in their lower back.Further information received on nov.1, 2017 reported that the patient thought the device had ¿backed her up¿ since they were unable to void.Also, the patient thought that something may have happened to the wire because they did not feel the stimulation right away while raising it.On nov.2.2017, the trial patient reported that there was still no progress made.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp): the serial numbers were not available.The cause of the controller turning off on its own was attributed to user error and was not resolved.The hcp was unsure as to why the procedure did not go well and there was no confirmed issue with the lead wire.The hcp also reported that retention and urgency were the symptoms the trial was intended to treat, and retention was pre-existing.There were no further complications reported or anticipated.

• Brand Name: VERIFY
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7049640
• MDR Text Key: 92656727
• Report Number: 3007566237-2017-04911
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 57