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

Model Number 3058

Device Problems Break (1069); Contamination (1120); Low impedance (2285); Material Deformation (2976)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported that during a stage 2 device implant procedure, one of the electrodes was ¿kinked a touch¿ on the way in.The third electrode appeared to be a little bent upon removing the extension cable.The physician noted it but didn¿t see a need to replace the lead.The impedance readings showed that electrode combination 0-1 was less than 50 ohms.The other impedances looked good.Based on the patient¿s bellow and motor responses during the impedance check, the physician decided to leave the lead in place and proceed with the battery placement.The cause of the impedance issue was not determined.The torque wrench was dropped so it was unusable and they were likely open another lead up to use the wrench.The patient was doing well and was scheduled to see the physician in two weeks.

Manufacturer Narrative

Concomitant: product id 3037, serial# (b)(4), product type programmer, patient.Product id 3 889-28, lot# va0mmm9, implanted: 2014-(b)(6), product type lead.Product id neu_wrench_acc product type accessory.(b)(4).

• 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: 4380330
• MDR Text Key: 5114415
• Report Number: 3004209178-2015-00083
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 01/05/2015
• Date Device Manufactured: 11/08/2014
• 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: 00044 YR