MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Energy Output Problem (1431); No Device Output (1435); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Device Overstimulation of Tissue (1991); Seizures (2063); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Complaint, Ill-Defined (2331)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had intermittent communication and every once in a while ¿it comes on¿.The patient needed the ins off for a procedure (unrelated to the implanted device) and they were finally able to turn it off.After the procedure, the patient went home and had trouble turning it back on although they finally got it back on.When the patient used the programmer during the report, they got poor communication.When it was confirmed that the antenna was securely attached and synchronized to the implantable neurostimulator (ins), the issue was not resolved.When the programmer was placed directly over the ins and synchronized the poor communication was still not resolved (poor communication occurred with and without the antenna attached).A new antenna was sent to the patient.It was noted that the patient was trying to turn the device off again because when they try it on the stimulation came on really high.When asked if it was still felt high, the patient did not answer.In addition, the patient reported that they started having problems/symptoms again (therapy stopped helping) and had been having to increase the stimulation as a result.This started a few months ago.It was noted that the patient saw the physician assistant (pa) who ¿messed around and said it was fine¿.However the patient mentioned they still had to ¿go up and up¿ to stop going to the bathroom.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

Further information provided by the patient indicated that they have seizures.There were no further complications reported as a result of this event.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7634231
• MDR Text Key: 112204243
• Report Number: 3004209178-2018-14212
• Device Sequence Number: 1
• Product Code: EZW
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 10/28/2013
• 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: 06/21/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 08/08/2018
• Supplement Dates FDA Received: 07/19/2018; 10/04/2018
• Date Device Manufactured: 05/04/2012
• 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): Other
• Patient Age: 76 YR