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

Model Number 3058

Device Problems Premature Discharge of Battery (1057); No Device Output (1435); Device Or Device Fragments Location Unknown (2590); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

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 who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation.It was reported that the device has not worked in years and it will not turn on.The patient mentioned nothing happens when she uses the programmer.During troubleshooting, while having the patient use the programmer, the programmer showed a poor communication screen.The patient noted that she was sure it was the same screen she saw in the past.The patient has not used it for a while.When asked if therapy was still helping with symptoms, the patient stated it helped for the first 2 years and then it stopped working.It has not helped for quite a few years.The healthcare professional (hcp) who implanted the device retired and the patient did not bother with it.The patient also said she read the implantable neurostimulator(ins) should last a long time but it lasted a few years.It worked probably half of the years.Troubleshooting was unable to resolve the poor communication screen.There were no further complications or anticipations reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).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: 7550569
• MDR Text Key: 109491281
• Report Number: 3004209178-2018-12069
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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,Followup,Followup
• Report Date: 06/11/2018

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: 07/28/2010
• 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: 05/25/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 06/11/2018
• Supplement Dates FDA Received: 05/30/2018; 06/11/2018
• Date Device Manufactured: 02/03/2009
• 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