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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Electric Shock (2554)

Event Date 07/01/2016

Event Type  malfunction  

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

The manufacturer representative (rep) reported that the patient felt a shocking sensation when walking through any security gate.This began when she walked out of a clothing store in (b)(6) 2016.There were no associated falls.She also had impedance issues on two electrodes, which the nurse mentioned to another rep.The nurse was not able to read one of the electrodes, also on case <(>&<)> 0.The rep did not know if the patient still felt the stimulation when therapy was turned off.The rep followed-up with the patient and ran impedances.The following abnormal impedances were measured on combinations at 1 volt and 210 microseconds pulse width: case <(>&<)> 0 was "???" and 0 <(>&<)> 3 was less than 50 ohms.The same impedance issues were seen when run at 1 volt and 300 microseconds pulse width.The rep intended to give the patient three alternative programs that did not include the use of 0 or 3 to see if that mitigated the shocking sensation.The patientindication(s) for use were urinary dysfunction, sacral nerve stimulation, and gastrointestinal/pelvic floor.

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 from the manufacturer representative (rep) reported they have not heard anything back from her which the thought it might mean she is better.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5915351
• MDR Text Key: 53552979
• Report Number: 3004209178-2016-17905
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2016

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: 07/14/2017
• 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: 08/09/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided; 10/03/2016
• Supplement Dates FDA Received: 10/25/2016; 09/25/2017
• Date Device Manufactured: 01/25/2016
• 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 Age: 38 YR