MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275)

Event Type  malfunction  

Event Description

It was reported that a patient was implanted three to four months prior to the report and had post-surgical pain related to the procedure.The clinic had the patient turn the device off until she got over the pain, so she hadn¿t had the device on very much.The patient was seen in the clinic on (b)(6) 2014 and had mostly been on program 3.Program 4 hurt her, and programs 1 and 2 weren¿t helpful.The patient noticed nocturia five to six times a night and was feeling stimulation in the right cheek and tailbone.She was reprogrammed and felt stimulation at the rectum.Impedance and the battery weren¿t checked at that visit.The patient called the office on (b)(6) 2014, she was still having pain, and it was getting worse.She turned her device off and was still having the pain.The patient was given 800 mg of ibuprofen.The patient called the office on (b)(6) 2014, was fine off the ibuprofen, and had been off of it for almost two weeks.She hadn¿t noticed much change in her bladder symptoms when the device was off.The patient was also taking an antibiotic every night for urinary tract infection prevention.She planned to turn the device back on.On (b)(6) 2014, the patient changed device programs.She couldn¿t feel the impulse and it sounded like the device was turned on.She was seen in the office the next day and had the device turned off for the past month per her doctor to see if it would help with her right cheek pain.During that time, the patient took three weeks of motrin for possible inflammation around the lead.When she turned the device back on, she didn¿t feel any stimulation.The patient had no stimulation sensation.The device impedances were checked and high impedance was seen.The electrode combinations of the case and 0, the case and 1, the case and 2, and the case and 3 all showed impedances greater than 4000 ohms.Other values were in the normal range, except for electrode combination 0 and 1 which showed less than 50 ohms.The patient couldn¿t feel stimulation even though they went up and down the lead at 5 or 6 volts where the patient typically felt stimulation at low values.A battery check was also done and one was normal, the other two had results of ¿???.¿ the two readings showed low longevity of 6 or 9 months and the battery was only three months old.It was thought that there was a short circuit in the case and lead, which is why they were getting errors and why the patient couldn¿t feel the stimulation.It was unknown if the case was bad to begin with or if it malfunctioned later.The patient had not had any falls or injuries.On (b)(6) 2014, the patient turned the device back on and didn¿t feel any stimulus.The following day she turned all three programs up to 6.0.She still didn¿t feel anything and hadn¿t had any help from the device since it was implanted.The device was turned off.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3889-33, lot# va0mp8d, implanted: (b)(6) 2014, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer, patient.(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 4376604
• MDR Text Key: 5115421
• Report Number: 3004209178-2015-24772
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 01/01/2015
• Date Device Manufactured: 08/07/2014
• 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: 00071 YR