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 03/10/2017

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 manufacture representative (rep) regarding a patient's implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Rep reported getting "???" on c1, c2, and c3.When the rep increased/decreased amplitude and pulse width (pw), the "???" would clear but then the remaining combinations would be greater than 4000 ohms.Rep states ins is in the pocket and they are just closing the patient now.There was no trouble inserting the lead.An impedance test was performed at 2.0v and 360 pw.Technical services specialist (tss) had rep run impedances at 2.5v and 120 pw.The "???" was cleared, but then everything else was greater than 4000 ohms.Tss had rep run at 2.0v, 360 pw.C1 and c3 had "???", c0 was around 3500 ohms, c-2 was around 900 ohms, and bipolar pairs were 1700-3600 ohms.The ins was being used for testing motor response.Rep states they did testing intra-op and it was great, patient's trial was good as well.Tss reviewed impedances may need time to normalize as they had good results with trial and intra-op response testing.Tss reviewed issue with measurement circuitry which may be causing issue with unipolar pair "???" and that this isn't an issue with the system itself (and they most likely won't use case in programming).No patient symptoms reported.No further patient complications have been reported as a result of this event.

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 received from the rep indicated that the patient had already been seen for follow-up before they had made it to the office.The symptoms were well controlled.There were no future office visits scheduled, so they were unable to check the impedance.The cause of the impedance errors were not determined.The rep attempted multiple changes of pw and amplitude at the initial check with and without the assistance of technical services.The information was confirmed and reviewed with the healthcare provider.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6403751
• MDR Text Key: 69946782
• Report Number: 3004209178-2017-05571
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

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: 09/28/2017
• 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: 03/10/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided; 03/20/2017
• Supplement Dates FDA Received: 03/21/2017; 10/17/2017
• Date Device Manufactured: 04/09/2016
• 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: 66 YR
• Patient Weight: 100