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

Model Number 3058

Device Problems Inadequate or Insufficient Training (1643); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2014

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 3889-28, lot# v011665, implanted: (b)(6) 2006, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead.

Event Description

Information was received from a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported the patient's leads were not checked at the time of a replacement ((b)(6) 2014) and did not get checked until (b)(6) 2016.At this time the patient was told there battery would only last another two years.The patient later reported the date of the appointment was (b)(6) 2016.The patient was down to only one working lead and this was causing the battery to decline quicker.The patient was upset by this as their first implant lasted eight years and felt the manufacturer representative (rep) should have checked and found that only one lead was working.No falls/trauma was related to the issue.No patient symptoms reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via manufacturer representative (rep) regarding a patient.It was reported there was high impedances on all electrodes, all greater than 4,000 ohms.The hcp ran impedances at 2v and there was no change.The patient was programmed on case and 2, the only programmable options.There were no symptoms experienced by the patient as they were receiving optimal therapy.The issue was resolved at the time of the report.

Event Description

Additional information was received from a patient.It was reported no one had called the patient regarding their prior complaint.The patient restated that their new implantable neurostimulator (ins) was not working correctly, they were tired of running to the bathroom and wanted new leads that were going to work correctly.The patient noted they felt stimulation a little but it did not help with their trips to the bathroom and they had no symptom relief.They mentioned only having one program and were unable to troubleshoot as they were at work.The manufacturer representative (rep) had told the patient that the manufacturer would not replace the leads and told them to file a complaint with the manufacturer.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a patient.It was reported the patient thought the healthcare provider (hcp) was not trained to check the implantable neurostimulator (ins) and the lead with the physician programmer (php) until 14 months after the surgery, which was at the beginning of 2016.The patient stated the hcp had told them that only 3 of the four contacts were working and that as a result the ins was draining/depleting at a much faster rate than it normally would.Information later indicated only one contact on the lead was working.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5664916
• MDR Text Key: 45478453
• Report Number: 3004209178-2016-09805
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/18/2019

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: 05/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/21/2016; 03/18/2019
• Supplement Dates FDA Received: 05/18/2016; 06/13/2016; 06/23/2016; 07/13/2016; 09/22/2017; 03/18/2019
• Date Device Manufactured: 12/02/2014
• 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: 54 YR