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

Model Number 37601

Device Problems High impedance (1291); Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387-40, lot# j0443941v, product type: lead; product id: neu_unknown_lead, lot# unknown, product type: lead.Other relevant device(s) are: product id: 3387-40, serial/lot #: (b)(4), ubd: 31-aug-2008, udi#: (b)(4); product id: neu_unknown_lead, serial/lot #: unknown, ubd: 31-aug-2008.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for dystonia, movement disorders.It was reported that they were performing intra-op testing after an insulation issue was reported.The insulation was separating from the 0-electrode contact.The caller indicated per the physician the extension was removed and cut in december, but the lead/extension connection was not affected and did not think the issue was caused today when attempting to disconnect the (cut) extension from lead.When performing electrode testing with the alligator clips they were 0,1 = 8 ,245 ohms.2,3 = 40,000 ohms.The physician didn¿t want to proceed with ins due to lead needing to be replaced.There were no further complications reported.

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# j0443941v, product type: lead.Product id: neu_unknown_lead, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the cause of what damaged the insulation of the lead was unknown.The impedance issue was noted for the first time during the extension revision when the doctor re-exposed the lead to connect.The issues were not resolved.Nothing was removed for analysis.There were no further complications reported.

Manufacturer Narrative

Product id 3387-40, lot# j0443941v, product type: lead.Product id neu_unknown_lead, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was noted that there was no date scheduled to remove the lead, but than information gathered later stated that the patient was scheduled to have all the dbs components removed on (b)(6) 2019.There were no further complications reported.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id: 3387-40, lot# j0443941v, product type: lead; product id: neu_unknown_lead, lot# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the items were removed and would not be returned.There were no further complications reported.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the customer discarded the device.No further complications were anticipated.

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.

• 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: 8448816
• MDR Text Key: 139727997
• Report Number: 3004209178-2019-05951
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR