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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 04/01/2018

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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient had their ins implanted in 2016 and they saw the low ins icon.The rep reported the patient had turned stimulation off prior to a dental surgery.The patient turned the stimulation back on and saw the low indicator.The rep stated there was a low impedance found.The rep reported the patient was seen and the following impedances were reported, c0 595 ohms, c1 1016 ohms, c2 1016 ohms, c3 607 ohms, 01 1049 ohms, 02 1049 ohms, 03 70 ohms, 12 1162 ohms, 13 1049 ohms, and 23 1049 ohms.The rep stated there was no indication of low z found in that pair used for programming.There was no trauma or falls possibly related to the issue.The rep reported the patient was scheduled for replacement on (b)(6) 2018.There were no symptoms reported.It was noted the patient had a dental surgery and low ins icon in (b)(6).The rep stated the impedance issue was found on (b)(6).Additional information from the manufacture representative (rep) on (b)(6) reported the patient called the healthcare professional¿s (hcp) office and the hcp had the rep come in to help determine the error code the patient received by checking the battery.The rep stated it could no t be determined if the dental surgery had any direct effect on the device because the patient had not used her patient programmer since the implant.The rep stated the patient turned off the device for surgery and when she went to turn it back on after the surgery she got the low battery image.The hcp office had no further information on the type of dental surgery.The rep stated they were not sure what the cause of the low impedances and low ins icon was.The rep stated the device would be returned after it was replaced on (b)(6).The rep noted the information was confirmed with the hcp.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.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (njy324927h) revealed no anomaly.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 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: 7612052
• MDR Text Key: 111428965
• Report Number: 3004209178-2018-13714
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2018

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: 10/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 11/05/2018
• Supplement Dates FDA Received: 08/28/2018; 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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: 42 YR
• Patient Weight: 133