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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Low impedance (2285)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative via a consumer regarding a patient implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the manufacturer representative (rep) was testing impedances at 1v, 2v and 3v and saw question marks or <(><<)>50ohms during testing with no therapy measurement.It was noted that patient was programmed to.6v and was getting great therapy.Patient noted sensation at 3v, but was able to tolerate the impedance test.The patient was seen by their healthcare professional a week ago, where they noted an issue and asked the patient to return to the clinic when the rep was present.No further complications were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that the physician ran additional impedance testing at higher pulse width (300) at 1v, 2v, 3v and 4v and the same results were seen.All impedances values were less than 50.Upon further questioning of the patient, they stated they were always sore around the battery site, but that they thought that was normal.The physician scheduled a full replacement on (b)(6) 2017 and turned off the interstim prior to sending the patient home.Patient provided no additional information regarding any precipitating event (falls, traumas, etc.) that could have led to device damage.The cause of the impedance issue was not determined.No further complications were reported.

Manufacturer Narrative

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: 6639736
• MDR Text Key: 77534375
• Report Number: 3004209178-2017-12840
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

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: 09/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 06/15/2017; 06/15/2017
• Supplement Dates FDA Received: 07/05/2017; 10/05/2017
• Date Device Manufactured: 03/23/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR