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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Low impedance (2285); Battery Problem (2885)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 3093-28, lot# v847451, implanted: (b)(6) 2011, product type: lead, product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: 3093-28, lot# v807715, implanted: (b)(6) 2011, product type: lead.Product id: 3093-28, lot# v807715, implanted: (b)(6) 2011, product type: lead.(b)(4).

Event Description

The health care provider (hcp) stated they had been using the initial lead along since she got the best response out of this.The hcp stated at 1.0v and 210pw, 0/3 are the only two pairs showing abnormalities and showing less than 50 ohms.There was no fall or trauma reported regarding this event.The patient was on program 1 which was at 0+, 2-, and 3-.Therapy impedance reported as: program 1 was showing???.The hcp stated patient had been using the same program all along even before she had ins replaced in (b)(6) 2014.It was reported that the out of range electrodes used in programming was causing therapy problem.The patient was programed at 5.4v as well.The representative mentioned that he has seen a few times that the capacity doesn't match up with the longevity on the clinician programmer and representative clarified it was the same patient in the call he was talking about.No outcome was reported regarding this event.A further follow-up is being conducted to obtain this information.The patient was diagnosed with urinary dysfunction/sacral nerve stim gastrointestinal/ pelvic floor.A follow-up report will be sent if additional information becomes available.

Event Description

Additional information received by the manufacturer representative reported that the cause of the impedance issues with the current implanted system was the same issue as with the first ins.The cause and the lot number of the lead were unknown.The patient was not receiving urinary symptom control.The patient was currently programmed around the impedance issue and was receiving effective stimulation.The cause of the impedance issue was not determined and unknown by both the healthcare professional and the company representative.The impedance issues had not been resolved and continued as there were currently no plans to revise the lead.It was further reported that when the battery becomes depleted and being replaced, the hcp was going to decide if they choose to revise the lead at that point.**please see manufacturer report #3004209178-2015-15719 for information on the patient's first ins.**.

• 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: 4988628
• MDR Text Key: 25483503
• Report Number: 3004209178-2015-15717
• 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: company representative
• Reporter Occupation: Other
• Report Date: 07/15/2015

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: 12/14/2015
• 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: Not provided
• Initial Date FDA Received: 08/10/2015
• Date Device Manufactured: 06/24/2014
• 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: 00076 YR