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)

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

Event Date 06/26/2014

Event Type  malfunction  

Event Description

It was reported that the patient had a successful percutaneous lead trial and now they were doing the implant.The health care provider (hcp) placed the lead, hooked it to the battery, and put the battery into the pocket.It was noted that the manufacturer representative then did an impedance test at 1v and 210 pulse width and 4 out of the 10 were showing ¿???¿ and then they changed the amplitude to 1.5v and 270 pulse width and ran impedances again and 7 out of the 10 were in the black with impedances above 4000 ohms and 2 out of 10 were showing ¿???¿.They disconnected the lead from the battery and wiped it off and put it back into the implantable neurostimulator (ins).It was reported that the manufacturer representative ran another impedance check at 1.5v and 300 pulse width and the pairs were case positive and 0 negative at greater than 4000 ohms, case positive and 1 negative had ???, case positive and 2 negative had ???, and case positive and 3 negative at 941 ohms.With the impedance check at 0 positive and 1 negative, 0 positive and 2 negative, 0 positive and 3 negative the impedances were greater than 4000 ohms and with 1 positive and 2 negative, 1 positive and 3 negative, and 2 positive and 3 negative the impedances were at 2405 ohms.It was noted that the manufacturer representative ran the impedances at 2 or 2.5v and 350 pulse width and this did not help on 0 negative and 3 positive.Then they tried 1 negative and 3 positive, 2 negative and 3 positive, and 3 negative and 0 positive and saw bellows and toes on the patient.

Event Description

Additional information received reported that the patient was closed up and the manufacturer representative programmed around the issue.It was unknown what caused the impedance issue however the manufacturer representative was able to program the patient who felt stimulation.It was noted that the patient was recovered and was doing well.

Manufacturer Narrative

Product id: 3889-28, lot# va0khg5, implanted: (b)(6) 2014, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer.(b)(4).

Manufacturer Narrative

The event was previously reported for serious injury but no serious injury occurred.The event is reportable for malfunction.

• 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: 3941510
• MDR Text Key: 4597463
• Report Number: 3004209178-2014-13156
• 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
• Report Date: 06/26/2014

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: 11/28/2015
• 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: 07/31/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2014
• Date Device Manufactured: 06/02/2014
• 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