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

Model Number 3058

Device Problems Pocket Stimulation (1463); Unable to Obtain Readings (1516); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Urinary Frequency (2275)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a health care professional via manufacturer representative regarding a patient implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had no symptom relief and the battery life was stating low after being implanted in (b)(6) of 2017.It was also stated that the battery impedance was reading low.No troubleshooting attempts were made and the issue was not resolved.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that battery life showed ???.No further complications were reported.

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-33, lot# va1fzt4, implanted:(b)(6) 2017, product type: lead.(b)(4) applies to the lead only.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional via manufacturer representative regarding a patient implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had no symptom relief and the battery life was stating low after being implanted in (b)(6)2017.It was also stated that the battery impedance was reading low.It was mentioned that the patient had a loss of therapy, symptoms were returning, and the sensation changed.Troubleshooting attempts were made and hcp ran impedance on all electrodes, conducted x-rays, and tried different program settings.The impedance testing showed all combinations passed except those including lead 0 (0 and 2 passed, and 0 and 3 passed).The hcp reported that when she went to reprogram, no matter what leads she picked, if they were all on the wire (0 neg +1, 1 neg 3+), the patient felt no sensation even with amplitudes greater than 3.It was stated that if the hcp made the case + than she felt sensation at amplitude about 0.8, but only the ins site and not the bicycle seat area or anywhere else.The hcp noted that this occurred regardless of which negative lead she used.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id 3889-33 lot# va1fzt4 (b)(4) implanted: (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.It was reported that the patient had a short showing between 0/3 (<(><<)>50 ohms).It was stated that the patient's longevity was 1-6 months (90-100% used).The manufacturing representative (rep) mentioned that the patient was not currently programmed on 0/3 and the patient was using 1.6v.The rep noted that they had been tracking her symptoms to make sure that she was getting benefit from her stimulation.It was reported that the patient just had her ins in (b)(6)2017.It was also reviewed that it could be likely that the short was programmed at one point in time due to 0/3 being a common pair to use in therapy or the low remaining life estimated on the ins given that the patient was only using 1.6v.There were no symptoms or further complications reported or anticipated.

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 2021-04-04, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the cause was not determined but the health care professional indicated that the impedance was low during an in-office visit on (b)(6) 2018.The manufacturing representative (rep) stated that programming was changed to program 7 to improve the patient's symptoms.It was noted that the impedances that were low were on electrodes 0 and 3 and they were read electronically today.The rep mentioned that the issues were not resolved at this time since the patient did not show up for her scheduled appointment.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

Product id: 3889-33, lot# va1fzt4, implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: (b)(4) 2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a manufacturer¿s representative (rep) indicating that they would be seeing the patient on (b)(6) 2018.The rep reported previously reported information, and noted that the patient¿s return of overactive bladder symptoms was the same with the stimulation off.The rep reported that the healthcare provider¿s office had done reprogramming and they were currently on program 7.No further complications were reported.

• 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: 7395637
• MDR Text Key: 104419955
• Report Number: 3004209178-2018-06423
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2018

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: 09/28/2018
• 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: 04/02/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 04/03/2018; 04/23/2018; 06/01/2018; 06/04/2018
• Supplement Dates FDA Received: 04/06/2018; 04/23/2018; 04/24/2018; 06/04/2018; 06/05/2018
• Date Device Manufactured: 03/31/2017
• 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