MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

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

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It was reported the patient was unable to adjust stimulation.Putting batteries in the programmer resolved that issue.The patient never had therapeutic effect.They could feel stimulation, but were urinating like prior to implant.The issue started a few months prior to call.The patient had to wear a diaper and pad.A week later, it was determined a urinary tract infection was the cause of the issue.Adjusting settings had not resolved the issue.A urine culture tested positive.Unipolar impedance measurements for electrodes zero and one showed ¿???¿.All other impedances were within normal limits.The patient had cancelled their follow-up appointment.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 3093-28, lot# v765390, implanted: (b)(6) 2011, product type lead; product id 3037, serial# (b)(4), product type programmer, patient.(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4478784
• MDR Text Key: 18070326
• Report Number: 3004209178-2015-01612
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

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: 02/28/2013
• 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: 01/12/2015
• Initial Date FDA Received: 02/03/2015
• Date Device Manufactured: 09/09/2011
• 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: 00079 YR