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

Model Number 3058

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Date 04/10/2018

Event Type  Injury  

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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had a stimulator replacement because they were having a problem with the stimulator and the therapy was no longer effective.The patient stated that they had an appointment on (b)(6) 2018 with their healthcare provider and manufacturer¿s representative, and it was determined that the stimulator battery wasn¿t strong enough, and it was decided to replace the stimulator.It was noted that the initial stimulator had provided them with immediate relief.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care professional.It was reported that the problem with the stimulator and loss of therapy was first noticed on (b)(6) 2018.The ins was reprogrammed on (b)(6) 2018, from program 4 at 5.4 to program 1 at 6.3 due to their urge urinary incontinence.On (b)(6) 2018, the patient stated that their ins was no longer working; it was interrogated, ¿battery low.¿ the patient was pleased with the ins and opted to proceed with replacement of the device.No further patient complications are anticipated or expected as a result of this event.

• 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: 7558634
• MDR Text Key: 109736403
• Report Number: 3004209178-2018-12306
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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: 12/28/2014
• 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: 05/01/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/05/2018
• Date Device Manufactured: 07/11/2013
• 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: 88 YR
• Patient Weight: 67