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 Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3093-28, lot# v038958, implanted: (b)(6) 2007, explanted: (b)(6) 2017, product type: lead.This device is included in the medical device correction, "unretrieved device fragments models 3093 and 3889 interstim tined lea ds", educational brief/physician communication (december 2010).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

Information received from a manufacture representative (rep) regarding a patient that was implanted with an implantable neurostimulator (ins) urinary dysfunction/sacral nerve stimulation.It was reported there was a partial explant of a lead.It was noted the patient was having the implantable neurostimulator (ins) replaced.The rep stated the lead was checked intraoperative and 2 electrodes were working.The lead was replaced.The rep stated upon removal of the old lead, it broke off within the patient.The rep stated the lead broke off during device explanation.The rep stated there was no environmental, external, or patient factors that may have led or contributed to the issue.The rep noted the issue was not resolved at the time of the event.There were no further complications that have been 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.Manufacturer representative reported the impedance check was performed and they were noted to be abnormal.It was also reported that the patient had a loss of therapy.It was reported that because of this the lead revision was done, but that a portion of the lead remains in the patient.No further information reported.

• 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: 6897654
• MDR Text Key: 87508577
• Report Number: 3004209178-2017-20145
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

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: 09/28/2008
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 04/03/2007
• 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: 34 YR