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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2016

Event Type  malfunction  

Event Description

A manufacturer representative (rep) reported they were doing an implantable neurostimulator (ins) replacement going from an ins with extension to a lead to just a ins with just a lead.The rep noted that the impedances with the old system were fine but with the new system ins impedances are greater than 4000 ohms expect on c-1, c-2 and 1-2.The rep stated they had already turned off all the room lights and increased amplitude to 4.3 v and pulse width to 300, but impedances were the same.The rep stated they had also removed the lead and wiped it down and reinserted and this didn¿t resolved the issue.There was no troubleinserting the lead, the rep noted the lead went all the way into the header.The rep performed electrode impedence test at 2.0 v and 360 pulse width.The rep stated the results were high, greater than 4000 ohms.The caller stated impedances were similar to initial testing with everything being over 4000 ohms expect c-1 was ???, c-2 was 682 and 1-2 was 860 ohms.The rep loosened the setscrew only slightly, removed the lead and then reinserted it, but twisted the lead while pushing it into the header block and the results were the same with the impedance test.It was noted an ins was being used for testing motor responses.The rep then used previous effective pairs that were high.The parameters were rate 14, pulse width 210 us, cycling at 3s on, 3s off and no softstart.The amplitude was increased with the clinican programmer.There was no bellows and toe flick present at normal amplitudes values.This process was repeated with different electrode pairs.There was no pairs that provided response.The rep tested 2-3+ -8.5 v, 1+3-5.0v, 0+3-7.0v, and 0+2-8.5v.The rep noted prior to replacement the patient was programmed on 1-2+.The rep then repeated motor testing using just alligator clips and no ins.The rep stated they tried all electrode combinations, the healthcare professional (hcp) stated that there did not appear to be any visible damage to the lead and they heard it torque down in the ins, they had done this 3-4 time.The hcp also noted when they initially had impedance issue they hooked the lead back up to the old ins and all impedances were normal.The hcp did not think it was a lead issue.There was no symptoms reported.The indication for use is unknown.

Event Description

A manufacturer representative (rep) reported it was unknown to why the impedance was high on all but three electrode combination.The rep stated the actions/interventions taken to resolve the high impedances were they had used a different battery but the impedances remained high.The rep noted the healthcare professional (hcp) decided to use the battery and placed the patient on electrode combination that was within normal limits.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the manufacturer representative (rep) reported the actions/interventations taken to resolve the high impedances were they spoke to technical services for approximately 45 minutes.They had tried changing to the amplitude and pulse width multiple times, they turned off the operating room lights, turn the device off, but had not success.The rep noted they hooked up the old battery at one point as well as the extension and did an impedance check with no issues at all.The rep stated this made them think the new battery could be a defective battery.The rep stated there were 3 electrode combinations that did not have impedance issues, one of which was the very program the patient had been on and the healthcare professional (hcp) felt it was okay to keep the battery in place, with the high impedance, and place the patient on the same program as before.The hcp did mention the patient was doing fine post operative.The rep noted the alternative would be that if the patient didn¿t see the same success the hcp would do a lead change and use the same battery, but it didn¿t appear that they would need to do so.

Manufacturer Narrative

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

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6039775
• MDR Text Key: 57977802
• Report Number: 3007566237-2016-03621
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• 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: 09/22/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/17/2016
• Supplement Dates FDA Received: 11/07/2016; 12/01/2016; 09/26/2017
• Date Device Manufactured: 06/14/2016
• 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: 64 YR