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

Model Number 3058

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient had an interstim on both sides.The patient stated she thought back in june she got a card that showed where they updated the battery on the left side, but not the right side.The patient noted at that point they didn¿t think that they needed to update the right side.The patient reported she had problems on the right side.The patient noted they went to the healthcare professional¿s (hcp) office and they were trying to check the battery on the right, but the hcp was not able to connect to the right side¿s battery.The patient she wanted to get a manufacture representative (rep) out to their next appointment on (b)(6) to recalibrate the battery on the right side or check the impedance for that battery.The patient noted they had recently noticed the problem on the right side, and also state that ¿it¿s just like a little, its not bad, bad like it normally is¿.The patient stated that before she moved the hcp originally check it and stated the battery on the right side would last about a year.The patient noted the hcp was unable to check the battery on the right side was at her last hcp appointment, 2 months ago, around the 4th of the month.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported they received our letter and they thought it was in regards to when they called to have a manufacturer representative come to their doctor's appointment because they couldn't read the stimulator.The patient thought they couldn't read it because there are 2 types of stimulators they were trying to read and they only dealt with pain, the patient's was for bladder.The patient had obtained a new urologist and was going to see them on (b)(6) to have the battery read to see if it was time for replacement.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.Patient reported that the right side is working but they are thinking that the battery is getting low and needs replacement.Patient has an appointment with dr.(b)(6) on (b)(6) 2018 to find out if the battery needs replacement.No further complications were noted or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 3058, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.Patient reported that the right side is working but they are thinking that the battery is getting low and needs replacement.Patient has an appointment with dr (b)(6) on (b)(6) 2018 to find out if the battery needs replacement.No further complications were noted 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: 7699271
• MDR Text Key: 115001987
• Report Number: 3004209178-2018-16066
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• 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: 07/16/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/01/2018; 08/01/2018; 08/08/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/31/2018; 08/01/2018; 08/01/2018; 10/03/2018; 10/04/2018; 10/04/2018
• Date Device Manufactured: 03/11/2015
• 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 Weight: 105