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

Model Number 3058

Device Problems Device Operates Differently Than Expected (2913); Compatibility Problem (2960)

Patient Problems Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient had a loss of therapeutic effect and her implant stopped working ¿about a year ago.¿ the healthcare provider (hcp) told her there was ¿no connection to the brain.¿ the patient stated that the device suddenly quit working for her and she started to have bladder infections.She had always had bladder infections, but while having the implant she did not have one for three years.Her implant was removed this year, but she did not remember when.It was also removed so she could get a mri.The patient was re-implanted in (b)(6) and was still on medication for the infection at the time of the report.No patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: 3889-28, lot# v340503, implanted: (b)(6) 2009, product type: lead.(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: 4296849
• MDR Text Key: 15126612
• Report Number: 3004209178-2014-22559
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2014

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: 03/28/2011
• 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: 11/14/2014
• Initial Date FDA Received: 12/04/2014
• Date Device Manufactured: 10/05/2009
• 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