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 Micturition Urgency (1871); Urinary Retention (2119)

Event Type  Injury  

Event Description

It was initially reported on (b)(6) 2014 that the patient requested compatibility guidelines for the ct/cat scans.The reason for ct scan was related to the reason he has neurostimulator therapy.The patient never had therapeutic effect.At first he thought it might have been helping his urgency and frequency but was not sure.The patient doesn't know when the symptoms returned.He doesn't know if therapy ever really worked for him.He met with manufacturer representative three times and has had reprogramming done.Tried increasing stimulation on his programmer and also trying all 4 programs.This last visit with the manufacturer representative, which was 2 weeks before reported event date, she found that "all 4 prongs weren't activated." the patient thinks manufacturer representative was made aware of the issue that his therapy wasn't helping him 2 weeks ago.The patient has gone through all medicines and has gotten botox as well.The day of the reported event date was the 8th day of botox.He has to self-catheterize 4-5 times a day.Even after he does this, within an hour he starts having severe urges.The patient¿s healthcare provider was looking for another underlying cause of this issue.He had bowel surgery before he had the implant 6-7 years ago which was back in 2008.Additional information received on (b)(6) 2014 from the healthcare provider noted that there was not a 50% or greater symptom reduction.The event cause was not determined.Reprogramming was needed.It was noted: "not working".It was also noted that the patient needed mri.It was noted that the patient had a loss of therapeutic effect (never had).The patient did not experience a loss of stimulation.Explant of the system was scheduled for (b)(6) 2014.

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot# va0ejmc, implanted: (b)(6) 2014, product type: lead.Product id: neu_pt m_prog, lot# unknown, 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: 4216777
• MDR Text Key: 5041822
• Report Number: 3004209178-2014-20738
• 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: Physician
• Type of Report: Initial
• Report Date: 10/23/2014

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: 05/28/2015
• 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: 10/23/2014
• Initial Date FDA Received: 10/31/2014
• Date Device Manufactured: 12/02/2013
• 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: 00053 YR