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

Model Number 3058

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-33, lot#: 0217384278, explanted: (b)(6) 2020, product type: lead.Product id: 3889-33, serial/lot #: (b)(4), ubd: 18-mar-2023, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer via the manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the device did not work as well as before.The lead migrated and was replaced.The event resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10837227
• MDR Text Key: 216317321
• Report Number: 3004209178-2020-19957
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/13/2020
• Date Device Manufactured: 03/27/2019
• 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
• Patient Age: 48 YR