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

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516); Inadequacy of Device Shape and/or Size (1583); Low impedance (2285)

Patient Problems Micturition Urgency (1871); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3093-28, lot# va098v6, implanted: (b)(6) 2013, explanted: (b)(6) 2017, product type: lead.

Event Description

Information was received from a patient via a company representative (rep).It was reported that rep assumed the patient was having an implantable neurostimulator (ins) replacement due to normal battery depletion but upon interrogation the device had 26-44 months remaining.The patient then stated she needed her lead replaced because the therapy was no longer working.Patient said when she had to void (urine) she would gush.Patient was unsure when it started.Patient stated may be within the last year.There was no fall or trauma related to the issue.Rep provided an impedance check was done before surgery and the 0<(>&<)> 2 electrodes were <(><<)>50 ohms.The chronic lead was explanted and a new lead was successfully placed.Upon visualization of the ins, there was visible dent in the lower left quadrant of the device.The new lead was attached to the existing ins and impedances were checked.At 1,2 and 3v, the output c <(>&<)>0 could not be checked (the reading was ????).The physician then elected to replace the ins and all impedances were then in range.The issue was resolved at the time of the report.Patient status was noted as alive, no injury.The indications for use for this patient were urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3093-28, lot# va098v6, implanted: (b)(6) 2013, explanted: (b)(6) 2017, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) model 3058 serial (b)(4) showed no significant anomalies and passed final functional testing.Due to the nature of the complaint, an impedance test was performed in 0.9% saline solution and good normal impedances were observed using a clinician programmer.It was determined there was good, stable output on the electrode pairs as received.Analysis also determined the telemetry was acceptable.It was also reported the ins can was dented.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: 6701698
• MDR Text Key: 79643121
• Report Number: 3004209178-2017-14578
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2017

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: 11/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/25/2017; 08/25/2017
• Supplement Dates FDA Received: 07/27/2017; 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2014
• 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 Outcome(s): Required Intervention