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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported that the patient¿s trial was mediocre and their healthcare provider told them to give it time and it would be better after implant.Since implant, the patient had been having issues with their therapy not working.The patient¿s programming had been set the day of implant an had not been changed since then.It was noted that no stimulation sensation was part of the issue.The patient stated there were time they didn¿t feel stimulation or it would stop and then they would feel it again.After implant, the patient had a couple of good days and a couple of bad days.The patient stated that for five days they felt nothing but had to turn the stimulation down because of a pain they felt that was like a bladder infection.When they turned the stimulation down the feeling got better but more symptoms returned.The patient turned the stimulation down three days prior to report.At the time of report, the patient was at 2.2 volts and when they sat they felt pulsing but it stopped right away and there was no pulsing.The patient still went to the bathroom 3-4 times at night, which was an improvement.The night prior to report the patient did sleep four hours straight and the day of report they went to the bathroom a good amount five times.It was noted that the patient did not know how to change programs and had only increased or decreased their stimulation.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 3889-33, lot# va0nnyh, implanted: (b)(6) 2014, product type: lead; product id 3037, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Follow up information received reported that the patient still had concerns with their device therapy but was working with their doctor/manufacturer¿s representative.The patient had a 6 month follow up appointment for (b)(6) 2015 and was still working on getting the right setting.If additional information is received, a follow up report will be sent.

• 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: 4376153
• MDR Text Key: 5285278
• Report Number: 3004209178-2014-24762
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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: 03/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2015
• Date Device Manufactured: 09/19/2014
• 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: 00060 YR