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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Erythema (1840); Foreign Body Reaction (1868); Unspecified Infection (1930); Pocket Erosion (2013); Skin Erosion (2075)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is estimated based on event date and age at time of study baseline.Concomitant medical products: product id neu_unknown_ext lot# serial# unknown implanted: (b)(6) 2016, product type: extension.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.It was reported the patient's extension migrated.The patient also experienced skin erosion and superinfection with a foreign body granuloma in the right frontal region, without heat, blush, edema or secretion.Interventions included administration of rifampicin and ciprofloxacin on (b)(6) 2019.Etiology was related to device/therapy, not related to procedure, and related to incisional site/device/lead/extension tract.The event was ongoing.No further patient complications were reported.

Manufacturer Narrative

Continuation of concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2018,product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2018, product type: extension.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from an hcp of a clinical study indicated the thorax presented a foreign body reaction 1.5 cm in dia meter, without secretion.They were administered 600 mg rifampicina daily and 1500 mg ciprofloxacina daily.

Manufacturer Narrative

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

Event Description

Additional information was received from a hcp.It was reported that on (b)(6) 2020 additional intervention of washing, debridement and flaps in: left frontal, right parietal and subclavicular right region.It was noted as a superinfection.The patient was administered vancomycin.

Manufacturer Narrative

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

Event Description

It was reported that the patient reported a suggestive picture of a foreign body reaction.There was exposure of the ins in the left subclavicular area that warranted urgent surgery, as there was risk of infection and damage to the ins.The patient's ins was re-positioned and their extension was replaced.It was noted the issue was related to the device/therapy and not related to the implant procedure.Diagnostic methods included a tissue culture, the results of which were negative.The patient was hospitalized and medications were administered; the event was considered ongoing.No further complications were reported as a result of this event.Additional information received from an hcp of a clinical study indicated the patient's ins had migrated.There was also site redness.Additional information was received from the hcp stating the issue resolved without sequelae on (b)(6) 2019.Additional information was received indicating the extensions have been explanted.There was exposure of the device with poor yellowing sequestration, without pain, has not presented fever.

Manufacturer Narrative

Product id: 3708660, serial# (b)(4), product type: extension; product id: 3708660, serial# (b)(4), product type: extension; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2018, product type: extension; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2018, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified that the extension migrated to the bicoronal surgical scalp scar which caused foreign body reaction and exposure of the extensions.

Manufacturer Narrative

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

Event Description

Additional information was received indicating that the clinical diagnosis was foreign body reaction in the thorax, at 1.5 cm diameter, without secretion.The medication administered was rifampicina at 600 mg per day.Noted as a "sobreinfection" on (b)(6) 2019, the patient was still on antibiotic treatment.There were no general symptoms.The parkinson's symptoms were very well.The extension migrated to the bicoronal surgical scalp scar causing the foreign body reaction, with exposure of the extensions.

Event Description

Additional information was received.The implantable neurostimulator (ins) and extension were explanted and not replaced on (b)(6) 2021.The event was considered resolved as of (b)(6) 2021.

Manufacturer Narrative

Section d information references the main component of the system, other applicable components are: product id 3708660 lot# serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type extension product id 3708660 lot# serial# (b)(6), implanted: (b)(6) 2018, explanted: (b)(6) 2021,product type extension.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 8466428
• MDR Text Key: 140431897
• Report Number: 3004209178-2019-06340
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR