MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Inflammation (1932); Staphylococcus Aureus (2058); Seroma (2069); Swelling (2091); Complaint, Ill-Defined (2331); Injury (2348); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0u148, implanted: (b)(6) 2015, product type: lead.Product id 3387s-40, lot# va0u148, implanted: (b)(6) 2015, product type: lead.Product id 3708640, serial# (b)(4), product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.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 was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the patient was in surgery to implant the leads, extensions, and implantable neurostimulator (ins) as no devices were present in the patient at the time of the surgery.The health care provider (hcp) believed that all previous devices were removed due to an infection.The date, hospital location, surgeon, and all other details related to the device explants were unknown.

Event Description

Additional information was received from a health care provider (hcp).It was confirmed that the whole system was explanted on (b)(6) 2016.It was reported that the infection began occurring on (b)(6) 2015.The hcp also noted that the following diagnostics were performed related to the infection: ct scans, labwork, cultures, iv antibiotics, oral antibiotics, and the explant.It was stated that during a office visit for fluid collection at the lead surgical site on (b)(6) 2015, there was fluid a interval decrease of postoperative pneumocephalus and subcutaneous air in the patient's scalp; a ct scan was performed.There was also mild scalp swelling and a subcutaneous edema at the superior left frontoparietal region without definite drainable collection; another ct scan was scheduled.It was also confirmed at this visit that there was no change to the lead positioning.During a follow-up visit on (b)(6) 2016 the previously reported swelling was noted to be resolved.Additionally, the noncontrast 5 mm axial ct scan images obtained with bone and brain algorithms from the craniovertebral junction through the vertex were reviewed and compared to ct images taken on (b)(6) 2015.It w as reported that there was no significant change to the lead positioning, but there was a mild soft tissue irregularity overlying the electrodes at the left posterior scalp.Another office visit occurred on (b)(6) 2015 where a left chest swab was used to gather cultures from the wound and it was noted that there was c reactive proteins (inflammation marker) and light growth of staphylococcus aureus at the left chest surgical site; additional testing was requested.On (b)(6) 2015, another left chest swap to gather cultures was performed and after 3 days, no growth was seen.Cultures were again taken on (b)(6) 2015, but were taken of the left side of the patient's head as the patient experienced wound sensitivity.The cultures resulted in light growth of staphylococcus aureus.It was then noted that the patient returned to the office on (b)(6) 2016 and cultures were taken from the patient's sternum that resulted in light growth of staphylococcus aureus.The system was explanted on (b)(6) 2016.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5680030
• MDR Text Key: 45956838
• Report Number: 3004209178-2016-10333
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Date Device Manufactured: 06/15/2015
• 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