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

Model Number 3058

Device Problems High impedance (1291); Human-Device Interface Problem (2949)

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

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3889-28, lot# va19u7w, product type: lead.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

A manufacturing representative (rep) reported that during a system replacement they were ran impedance at 2.6v and 360pw and they were getting over 4000ohms o all combinations, except a few case combinations.When they tested the lead with the test cable they were able to get good bellows and toe responses under 2.0v.They already took out the lead, rinsed it, wiped it down and reinserted, but obtained the same results except c-0, c-1 and c-2 were in range.They stated there was no bovie near the system, no x-ray in the room and no lights directed at the system.They also used an ins to test the responses.Additional troubleshooting had the rep use rate-14, pw-210us, set cycling at 3s on/3s off.No softstart, increase amplitude with the clinician programmer.It was noted that bellows and toe flick were present at nominal amplitude values.They tried another bipole pair to confirm programming options on the lead.They tested combinations and received the following responses: 0-3 3.3v, to, less bellows; 1-3 3.0v, toe, bellows are hard to see; 2-3 2.8v, toe, bellows; 0-1, 3.0v, little toes, bellows.The rep ran impedance again at 2.6v 360pw and still got greater than 4000ohms on all combinations except a few case pairs.There were no symptoms reported.Follow up with the rep noted that they replaced the lead and the patient felt stimulation appropriately, post operation, in the vagina, at 2.0 or less on all first 4 standard programs.The rep stated they would be returning the lead.The ins was indicated for urinary dysfunction/sacral nerve stimulation/gastrointestinal/pelvic floor.

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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6151809
• MDR Text Key: 61643806
• Report Number: 3004209178-2016-25339
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Date Device Manufactured: 10/20/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR