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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hematoma (1884)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot#: 0209392701, implanted: (b)(6) 2015, product type: lead.Product id: 3387-40, lot#: 0209375825, implanted: (b)(6) 2015, product type: lead.Product id: 3387-40, lot#: 0216184579, implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3387-40, serial/lot #: (b)(4), ubd: 20-feb-2019, udi#: (b)(4); product id: 3387-40, serial/lot #: (b)(4), ubd: 20-feb-2019, udi#: (b)(4); product id: 3387-40, serial/lot #: (b)(4), ubd: 10-may-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent implantation of the deep brain stimulator (dbs) to left gpi for dystonia.Five years ago they were implanted bilaterally stn for parkinson's disease.The procedure was commenced as per usual, burr hole performed mer.Nothing was noted to be unusual.Intra-operative xrays performed.On removal small amounts of blood in mer cannula were observed.The lead was implanted and an x-ray was performed.Leads from previous implant observed that one was displaced.Curvature was evident.A ct scan was performed and a large basal ganglia haematoma was evident with a mid line shift.The patient returned to the operating room and a emergency ventricular cather was inserted and external ventricular drain was attached.Csf was drained.No obvious blood staining evident.Both pupils were reactive and the patient remains intubated.They were transferred to the intensive care unit.The issue is not yet resolved.

Manufacturer Narrative

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

Event Description

Additional information was received reporting that the hematoma was attributed to the insertion of the mer electrode which is believed to have ruptured a vessel, causing the bleed; and therefore the swelling from hematoma impact the installed lead causing it to displaced.A ct was performed a large basal ganglia hematoma was evident with a mid line shift, the patient returned to the operation room and the emergency ventricular catheter was inserted and external ventricular drain attached.Csf was drained and no obvious blood staining was evident.The patient remained intubated and was transferred to the icu.The continue to have daily ct's which have shown that the haematoma has not increased in size.They have not received detailed information on the medications prescribed except that a standard protocol for haematoma, haemorrhage was provided.The patient is breathing unassisted, tube remains and swallowing needs to be assessed before removal.They responded to simple commands such as hand squeezes and eye blinks.The patient has been discharged from the icu, and transferred to a ward.This was confirmed with the physician.

Event Description

Additional information was received reporting that the patient has made a phenomenal recovery with negligible lasting effects of the haematoma.She has returned home, is self-caring and actually has had an exquisite result in the control of her dystonia, which the medical team suspects is a result of the therapy and the basal ganglia haematoma which has likely had synergistic effect not unlike a lesion.The patient will continue to be monitored and will have another ct scan in the future to assess any changes.Overall a great result and outcome.

Manufacturer Narrative

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.

Manufacturer Narrative

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.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: 10322105
• MDR Text Key: 200428553
• Report Number: 3004209178-2020-12819
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2020

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: 12/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/27/2020; 08/23/2020; 10/09/2020
• Supplement Dates FDA Received: 07/28/2020; 08/24/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR