MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Skin Erosion (2075); Discomfort (2330); Complaint, Ill-Defined (2331); Sweating (2444); Electric Shock (2554); Fluid Discharge (2686)

Event Type  Injury  

Event Description

It was reported that there was an infection.The patient had had the device for a year and it was removed due to bacteria on her skin which had caused an infection.The healthcare professional had done testing for (b)(6) and 3 other cultures which had all come back negative.Infectious disease was running tests as well.For the past 6-7 months prior to the date of this report it had been getting sore and on the right side there was blood gathering but no drainage.The patient felt like they were being cut from the inside.The battery was still functioning and stimulation was at 4.0v.Eventually on (b)(6) 2015 the implantable neurostimulator (ins) had broken through the skin and the patient was seeing a clear yellow fluid with no pus or odor.The patient had called the healthcare professional the following day.On friday (b)(6) 2015 there was more drainage, the patient had pressed on it and took an alcohol pad and saw pus and some green stuff as she cleaned the dead skin off and then she saw the battery tip.The patient was taken to the emergency room via ambulance where they drew some blood and took out the ins on (b)(6) 2015.The patient was on antibiotics for 4-7 days and medication for dystonia.The patient doubted that it was an infection and prior to the device coming out it had been shifting and had gone in to her arm pit.The patient had not had any fevers, had not felt sick or had night sweats and felt the battery fluid was leaking out of the ins.The patient had had lab work done in (b)(6) prior to the date of this report and everything was fine.The patient stated that ¿all of a sudden this clear yellow fluid was coming from the battery started leaking out and it ate her skin.¿ the patient was getting electrical surges in her head which would happen a couple of times a day.The patient was scheduled to see their healthcare professional on (b)(6) 2015.The healthcare professional stated the bacteria on the skin had caused all the issues.The patient stated that she had had the battery for 4 years and worked in a hospital and never had this happened before.The patient could feel the battery shifting and one day there was sweat on shirt and here the battery had opened a clear yellow odorless.The patient believed the battery was faulty.The past month prior to the date of this report had been terrible, the patient could not work, drive, or watch tv.The patient stated that the ins ate through her skin and was all taken out.Components involved were ins, extension and pocket adaptor.The ins protruded the skin.No troubleshooting was done.The action taken was explant.It was device related, they suspected there was increased bulk by adding the pocket adaptor which pushed the ins into the skin leading to breakdown.Patient outcome was unknown.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Product id 64002, lot# n386022, implanted: 2013 (b)(6); product type adapter product id 37642, serial# (b)(4); product type programmer, patient product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v553427, implanted: 2010 (b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v550216, implanted: 2010 (b)(6); product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4577485
• MDR Text Key: 5451275
• Report Number: 3004209178-2015-04323
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2015
• Date Device Manufactured: 09/20/2013
• 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: 00057 YR