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

Model Number 37601

Device Problems Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3389s-40, lot# va0g9lu, implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.Product id: 3389s-40, lot# va0g9lu, implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: lead.Product id: 3389s-40, lot# va0g9lu, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: extension.Product id: 3708640 serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: extension.

Event Description

Information was received from a consumer via a manufacturing representative regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had an infection at the ins pocket site, and had the system explanted as a result.The patient was alive with no injury at the time of this report.Furthermore, it was reported that one of the leads was implanted after its use-by date.No further patient complications were reported as a result of this event.

Manufacturer Narrative

(b)(4).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

Additional information was received indicating that there were only two leads explanted at the time of the surgery; there was no third lead implanted after its use-by date.No further patient complications were reported as a result of this event.

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6638362
• MDR Text Key: 77477691
• Report Number: 3004209178-2017-12803
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Date Device Manufactured: 01/13/2017
• 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: 61 YR