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

Model Number 3058

Device Problems High impedance (1291); Human-Device Interface Problem (2949)

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via 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 the patient was seen in office because they had a return of incontinence issues.The staff checked the lead and found high impedances, so the patient was scheduled for a replacement.When the patient was flipped to prone, the healthcare provider asked the rep to check battery longevity; it showed 43 months left.When the healthcare provider opened the pocket, the battery came loose from the lead without using the screwdriver.The healthcare provider connected the implanted lead to the implanted battery and 3 audible clicks were heard.The healthcare provider tugged on the lead and it remained in place.The battery was placed back in the pocket and an impedance check was done; no impedances were shown.The healthcare provider closed the patient with the original devices implanted, and the issue was noted to be resolved.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

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

Event Description

Follow up information received from the manufacturer¿s representative reported that, to clarify the issue, the healthcare professional (hcp) pulled the battery out of the pocket and the lead came loose from the battery without using the screw driver.The cause of the disconnection/high impedance issues were not determined.There were no further complications reported or anticipated.

• 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: 9205297
• MDR Text Key: 162981941
• Report Number: 3004209178-2019-19878
• 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
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Date Device Manufactured: 07/14/2017
• 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 Outcome(s): Required Intervention