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

Model Number 3058

Device Problems Energy Output Problem (1431); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient¿s stimulator seemed to be working for the past 3 months but now she noticed she was having issues after getting back from vacation.The patient clarified that she was referring to having a loss of therapy/return of symptoms.The patient stated that she had to turn her stimulator on and off multiple times due to the airport security and wondered if the change in therapy was related to turning the stimulator on and off so often.The patient stated that she noticed when she turned the stimulation back on, that it "almost hurt" and it seemed too strong.The patient reported that she tried decreasing the stimulation, which did not resolve the issue but then tried changing the program, which did resolve the uncomfortable stimulation.The patient reported that since implant, she has noticed she continues to have a problem with liquids.The patient noted that she had the stimulator implanted for incontinence, and that most of her "every day" was fine (typically gets 50% symptom control) and no longer wears depends.However, she has trouble with her symptom control when she consumes liquids, especially alcohol.When the patient was asked if the symptoms were sudden or gradual, the patient replied that she did not know.The patient reported that the healthcare provider (hcp) prescribed her something to help relax her bladder as well.The patient noted that the prescription began after her implanted stimulator.The patient stated that she changed to p2, and that she has tried all 4 programs available on her patient programmer (pp) and they seem "okay", but the patient inquired if other programs can be added.Patient services reviewed programming considerations.Patient services reviewed that it takes time for the body to respond to therapy, therefore titrations should be discussed with their healthcare provider (hcp).The patient was redirected to follow up with their hcp to discuss symptoms and programming.No further complications were anticipated/reported.

Manufacturer Narrative

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: 7751958
• MDR Text Key: 116901500
• Report Number: 3004209178-2018-17429
• Device Sequence Number: 0
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 06/14/2019
• 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: 07/31/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 12/26/2017
• 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
• Patient Age: 45 YR