MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Low Battery (2584); Device Or Device Fragments Location Unknown (2590)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3093, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) who reported that the patient's battery was going bad and the patient's body started rejecting the implant so the patient ended up having the implant removed a few months prior to the call.According to the caller the patient had "new ones put in since then" which was clarified to mean since (b)(6) 2012 and that a wire had now been left in when the implant was taken out and now the patient had an infection and needed an mri.The caller reported that they thought that the infection may have been caused from where the "implant box" was removed.The caller was not sure which ins was involved with the reported allegations and patient status is unknown at the time of this report.There were no further complication reported or anticipated.

Manufacturer Narrative

Correction: additional review of the file determined that the following information was missing from the description: the caller indicated that the healthcare provider refused to remove the lead.The main component of the system and other applicable components are: product id: 3093-28, lot# va01khv, implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a manufacturer¿s representative stating that the patient had the device explanted but was told that the lead remained.The patient was seen by their healthcare provider for consult, and an x-ray was done showing that the lead was still in the sacrum.The issue was not resolved at the time of the report.No further complications were reported.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7053131
• MDR Text Key: 92771066
• Report Number: 3007566237-2017-04925
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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 Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention