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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va200bv, implanted: (b)(6) 2019, explanted: (b)(6) 2020.Product type lead.Date is estimated; year is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative regarding a patient who was implanted with an implantable ne urostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient lost symptom control after 1-1.5 years.The battery was stated by the provider that it would not hold a program change due to battery failure.Impedances were all out of limits until they were run at "a high amplitude and pulse width," then they were within normal limits.The patient was set at 1.0 volts with vagina sensation on program 6 - electrode 1<(>&<)>2 (-), and 0 (+).They tried to change the setting on the battery and they would not save.The provider called it a "battery failure." the lead and ins were explanted/removed and replaced with a competitor's system.The issue was resolved at the time of the report.The patient called the manufacturer representative to inquire about the warranty of the implants.A message was left with the warranty department to obtain information for the patient.Additional information was received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the impedances that were out of normal limits were not documented as high or low by the provider, and they did not remember.When asked to clarify what was happening, the provider responded, "the implant would shut off randomly and then zap [the patient] again and then not work." the reason why was unknown and never determined.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11995417
• MDR Text Key: 266072806
• Report Number: 3004209178-2021-09342
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2021

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: 10/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/14/2021
• Date Device Manufactured: 04/22/2019
• 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: 51 YR