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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/19/2016

Event Type  malfunction  

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).The rep reported that when connecting the old ins to the new lead the hcp noticed fluid inside the ins where the lead connected.The rep reported that they ran an impedance check a few times due to 4-6 ????¿s on the screen.The rep reported that the hcp did not want to risk the patient having issues after closing, so the hcp requested a new ins at that time.The rep reported that impedances were tested on the new ins and all were clear.No patient symptoms reported.

Manufacturer Narrative

Analysis of the ins, (b)(4), found that the product was functionally okay with insignificant anomalies.Product analysis # (b)(4) the tecothane acts as a shell during manufacturing to stack the connector components and make the welds.Once this is complete, the entire area is filled with the lsr.The lsr bonds well with the metallic and rubber components.However, the lsr does not bond well with the tecothane.This causes a tight, but not bonded fit.Body fluid in this space is not of concern because all of the electronic components are still completely sealed in the lsr and never cause any performance issues.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

No new information received.

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: 6239333
• MDR Text Key: 64432326
• Report Number: 3004209178-2017-00585
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2017

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: 05/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided; 01/20/2017
• Supplement Dates FDA Received: 02/02/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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 Age: 63 YR