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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Low Battery (2584); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Dysuria (2684)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor who reported that the patient was encountering poor communication and that they had a bowel accident without knowing it.Additionally, the patient indicated that they had a slight return of urinary urgency and difficulty voiding and the patient did not think the device was working, but the patient did not think that the ins was turned on and was unable to increase or decrease stimulation.The patient also thought that the ins could be depleted.The patient was implanted approximately 6 years prior to the call and thus it was suggested that the patient should have the implant interrogated to determine system status.Additionally, the patient noted that they were no longer feeling the stimulation in their toe.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.

• 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: 7664520
• MDR Text Key: 113301418
• Report Number: 3004209178-2018-15083
• 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: Other
• Type of Report: Initial
• Report Date: 07/05/2018

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: 10/14/2013
• 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: 07/03/2018
• Initial Date FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2012
• 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 Age: 51 YR