MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Impedance Problem (2950)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: all codes applied to product id: neu_unknown_lead only.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional (hcp) regarding a patient who had an implantable neurostimulator for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient was being considered for mri of knee unrelated to device/therapy but x-ray imaging was showing 3-4 small bead in sacral area that caller suspected was part of past interstim system that was removed.Per patient, they only had one interstim system and they wanted to have the removal/explant because they didn't want to deal with it anymore.Additional information was received.It was reported that the health care professional (hcp) hasn't seen the patient in 2 years.The hcp reported at the time of ins and lead removal there was some redness and erythema to the incision area of the ins.The hcp noted that the ins site and lead site were cultured.It was also mentioned at the time of surgery that the right lead broke both the times and was unable to be removed intact.It was reported that post-operative diagnosis was end of service ins and a lead with increased impedance.There were no further symptoms or complications reported or anticipated.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7625642
• MDR Text Key: 111900549
• Report Number: 3004209178-2018-14003
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 03/31/2010
• 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 Weight: 74