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); Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2018 (b)(4) (rep): information was received from a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that when the manufacturer representative tested impedance during the implant procedure they got ¿??? or it blacked out;¿ the impedance check ¿were blacked out.¿ it was noted that they increased the impedance test to 2 volts and 360 pulse width.It was also reported that the healthcare provider unscrewed the setscrew to pull the lead out and reinsert, but the setscrew was lost.It was clarified that device issue was with both the ins and setscrew but the cause was unknown, and that the setscrew was not lost, it just would not tighten.Another ins was used to finish the implant.There were no patient complications reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the screw was not seated correctly in the device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Analysis determined that the setscrew of the implantable neurostimulator (ins) was backed out beyond the point of being able to engage with the connector block and was cross-threaded.An attempt was made and was successful to screw the setscrew back into place and functional testing was performed.Was able to get good stable output on all circuits with known good lead.An impedance in saline test was performed and normal impedances were measured on all circuits and electrode pair combinations.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: 7349326
• MDR Text Key: 102851163
• Report Number: 3004209178-2018-05279
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

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: 07/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/26/2018; 05/03/2018
• Supplement Dates FDA Received: 03/27/2018; 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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: 78 YR