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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

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

Event Date 03/21/2016

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

Information was received from a company representative regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that they had no issue inserting the lead into first or second implantable neurostimulator (ins).They performed electrode impedance test at 1.5v and 360pw.The impedance read high 4000 ohms.They reran impedance test several times on the call at difference settings.They initially saw c-3 with question marks and all bipolar pairs, except 2-3 greater than 4000 ohms.They ran impedance again and question marks cleared and only the following pairs were showing greater than 4,000 ohms: 0-1, 0-2, 0-3, 1-2.It was indicated the ins was being used for testing motor response.They programmed and used previous effective pairs or pairs that were currently high at rate 14, pw 210us, cycling set at 3s on and 3 s off, no soft start.They increased amplitude with physician programer(pp).They saw motor response with the following pairs at the noted amplitudes 0-1 - 0.7v 0-2 - 2.1v 0-3 - 3.2v 1-2 - 1.6v.It was indicated that since high impedances pairs were providingmotor response and high impedances might resolve post-op, it would be appropriate to close patient.

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 manufacturers' representative reported that the impedance issue resolved however; the cause was not determined.

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: 5578777
• MDR Text Key: 42757289
• Report Number: 3004209178-2016-07512
• 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: 05/23/2016

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: 07/28/2017
• 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: 03/21/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided; 04/29/2016
• Supplement Dates FDA Received: 05/23/2016; 09/21/2017
• Date Device Manufactured: 02/05/2016
• 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: 00069 YR