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

Model Number 3058

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are product id: 3093-33, lot# v455950, implanted: (b)(6) 2010, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that patient's lead broke upon the removal of their depleted ins from body leaving the electrode portion of the lead in the body.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

This device is included in the medical device correction, "unretrieved device fragments models 3093 and 3889 interstim tined lea ds", educational brief/physician communication ((b)(6) 2010).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the cause of the lead breaking upon removing the depleted implantable neurostimulator (ins) was not known.No further complications were reported/anticipated.

• 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: 7168353
• MDR Text Key: 96519282
• Report Number: 3004209178-2018-00307
• 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,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

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: 05/28/2011
• 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: 12/19/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/19/2017; 01/29/2018
• Supplement Dates FDA Received: 01/16/2018; 02/02/2018
• Date Device Manufactured: 12/08/2009
• 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: 56 YR