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

Model Number 3058

Device Problems Degraded (1153); Low Battery (2584); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3093-28, lot# v819350, implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had symptom return about a month ago and had urine running down their legs in the morning.Patient stated they had been through 40-50 pads per week.The doctor checked patient's ins and determined the battery was depleted.Upon replacement, their doctor told them they had never seen corrosion like what the patient had on their lead wire to the ins.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care professional and it was reported that the patient likely had normal battery depletion.The cause of the corrosion was not determined.No further complications were reported.

Manufacturer Narrative

Information references the main component of the system and the other applicable components are: product id: 3093-28, lot# v819350, implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con) via a manufacturer representative (rep).It was reported that the patient was going to ask their physician about the device that was removed and send it back.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.¿ device code :(b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information patient was scheduled for typical normal battery depletion replacement, lead and device look abnormal and was sent back for analysis.The patient recovered without sequela.

Manufacturer Narrative

The other applicable components are: product id: 3093-28, lot# v819350, implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that the interstim worked "good" until a few months ago.The patient reported they had a terrible time controlling their urine and they didn't get a warning that they needed to urinate and they couldn't hold it in.The patient reported that many times, even out in public or in a store they urine would run down their legs.The patient noted they wore overnight pads for protection but that they weren't much help.The patient reported they would be up during the night several times soaking of urine and they had to change the sheets.They reported when they saw their health care physician (hcp) the hcp told them their battery was dead and the patient stated they couldn't go on the way things were and they decided to have their second interstim done.After the operation, the hcp told the patient the lead from the battery was corroded and that they had never seen that in all their days of practice.The hcp reported they would be sending the device back to medtronic.The patient reported they went through a terrible time with lots of discomfort and embarrassment out in public and at home.The patient reported they used roughly 40-45 of the thickest pads per week and they stated they felt they should be compensated for all they went through.There were no further complications reported/anticipated.

Manufacturer Narrative

Product analysis (b)(4):analysis information -- (b)(4) 2018 17:46:05 cst pli# 10 product id# (b)(4) analysis determined that the implantable neurostimulator (ins) output and telemetry were acceptable; however, the battery is near normal battery depletion.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.A computer longevity estimate was completed based on the parameters the device had when received for analysis.Product id (b)(4) lot# v819350 implanted: (b)(4) 2011 explanted: (b)(4) 2017 product type lead analysis identified that the conductor(s) was/were broken in the body of the lead at or near the tines and no electrical shorts were identified between the circuits.Analysis identified markings on the outer insulation of the lead which is consistent with markings from the use of a tool.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7133697
• MDR Text Key: 95512386
• Report Number: 3004209178-2017-26339
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/29/2017; 01/09/2018; 01/16/2018; 02/07/2018; 03/29/2018
• Supplement Dates FDA Received: 01/03/2018; 01/11/2018; 02/05/2018; 02/12/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2011
• 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: 74 YR
• Patient Weight: 69