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

Model Number 3058

Device Problems Unexpected Therapeutic Results (1631); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Urinary Frequency (2275)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va04h0y, implanted: (b)(6) 2013, product type: lead.Product id: 3889-28, serial/lot #: (b)(4), ubd: 08-nov-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient reported that he got a replacement device and since then, it is not working as well.Patient is still urinating more and patient reported the old device was better.Patient said he called the manufacturer representative on (b)(6) 2019, three days after the implant, and he turned up the stimulation.Patient reported that he has an appointment next wednesday and he is hoping that the manufacturer representative will be there and will let him increase the stimulation more.Patient reported the stimulation is at 2.6 volts and the healthcare professional (hcp) said he can go up to 3.0 volts but told him to give it ten days for it to work.Additional information was received after the patient's appointment with the hcp on (b)(6) 2019.Patient reported he has to urinate every hour and a half to every two hours mostly during the day.He said at night he stops drinking at 6:30-7:00 pm and has to go at 4, 5, and 6 am.The hcp informed the patient that two of the four wires are not working.The hcp increased stimulation more and told the patient that if it isn't working in 4 to 5 days, he'll need to have the leads replaced.No further complications were reported.

Manufacturer Narrative

Product id 3889-28, lot# va04h0, implanted: (b)(6) 2013, explanted: (b)(6) 2020.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 indicating that the cause was not determined for the leads not working, they were not told why they weren¿t working.When asked for the actions taken to resolve the lead issue, the patient indicated their healthcare provider would install new leads on (b)(6) 2020.No further complications were reported.

Manufacturer Narrative

Correction: after further review, device code (b)(4) and eval code (b)(4) do not 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: 9559123
• MDR Text Key: 179287788
• Report Number: 3004209178-2020-00352
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Date Device Manufactured: 08/09/2018
• 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: 75 YR
• Patient Weight: 84