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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Urinary Frequency (2275)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as follows: loss of therapy (b)(6) 2018; residual stimulation feeling: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that, about a week and a half ago ((b)(6) 2018), the device wasn¿t ¿working properly¿ and the patient felt like they had to go, that they kept leaking (loss of therapy).This occurred in (b)(6) 2018.The family member called the ¿local person¿ where it was suggested to turn the device off and leave it off for 24 hours then start it back on.The device was turned off on (b)(6) 2018 but the patient still felt the stimulation and it seemed to be getting stronger.They met with the local person last night and it was made sure everything was off and all the programs were off.It was reviewed with the reporter that some residual stimulation would be expected but usually not for this long.It was noted that the healthcare professional (hcp) had already done an mri and that an x-ray was scheduled for tomorrow morning ((b)(6) 2018).It was advised the patient follow up with their hcp for the issues.There were no further 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 healthcare professional.The hcp provided previous exam notes which showed: it was reported that at exam on 2015-08-25 the patient reported he was doing very well with the implant with a decrease in frequency.The patient noted intermittent stim in the left leg.Patient had another follow-up appointment on (b)(6)2016 and also was pleased with the therapy and had minimal stimulation in the leg.On (b)(6)2018 the patient was seen with a complaint of acute urgency and frequency over the past several weeks.The patient denied pain or burning.The patient voids every 5min ¿ 45 minutes and does not feel he empties.The hcp examined the patient on (b)(6)2018 and reports the patient was doing well until one month ago.The patient had back and left leg pain which he felt was related to the device so multiple programs were changed and ultimately the device was turned off.The hcp reported the patient would like the device removed, which the hcp plans to do in the near future, approximately one week.The hcp discussed with the patient that it may be the spinal nerve, and he may need further evaluation.Patient was advised to go to the ed if pain is worse or if he gets lower extremity weakness.Medical history was also provided: patient has had enlarged prostate for about 6 years, gets up at night to urinate 3 times.Patient¿s current medications include trazodone.Bph (benign prostatic hyperplasia) without obstruction and incontinence diagnosed 2015, urge incontinence/frequency diagnosed 2016, frequency of micturition diagnosed (b)(6)2018, history of kidney stone upon examination the patient showed no outstanding issues: no fever, chills, denies chronic back pain, denies numbness or tingling.There were no further complications reported or anticipated.

• 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: 7440595
• MDR Text Key: 106251862
• Report Number: 3004209178-2018-08324
• 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,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2018
• Date Device Manufactured: 06/10/2015
• 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: 54 YR