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); Compatibility Problem (2960)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2014

Event Type  Injury  

Event Description

Additional information received noted that the patient had the lead fragments removed by a spinal surgeon.The manufacturer's representative did not have outcome for the patient after the fragment removal.The doctor did not have the outcome for the patient either as the patient was no longer an interstim patient and not under this doctor's care.

Event Description

It was reported that a patient had an explant procedure so she could get an mri for hip pain.A healthcare professional (hcp) removed the implantable neurostimulator (ins), went to the introducer site, brought the lead from the pocket to that site, and attempted to remove it.The hcp ran into some resistance and ¿cut down a bit.¿ the lead was damaged and lead breakage occurred during explant.One of the tines and all of the electrodes were still within the patient.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id: 3889-28, lot# va01ha3, implanted: (b)(6) 2012, product type: lead.Product id: 3037, serial# (b)(4), implanted: (b)(6) 2008, product type: programmer, patient.(b)(4).This device is included in the medical device correction, "unretrieved device fragments models 3093 and 3889 interstim tined leads", educational brief/physician communication (december 2010).

Manufacturer Narrative

(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4174578
• MDR Text Key: 5300505
• Report Number: 3004209178-2014-19753
• Device Sequence Number: 1
• Product Code: EZW
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2014

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: 12/28/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2014; 11/26/2014
• Date Device Manufactured: 07/10/2012
• 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): Other
• Patient Age: 00039 YR