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

Model Number 37601

Device Problems Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 3389s-40, lot# va1q1sr, implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: va1q1sr, (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp)via manufacture representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins) for parkinson's dual and movement disorders.It was reported that the surgeon felt like the lead looked compromised, but the impedances ended up fine on the first try and the patient was asleep.No external or patient factors that could have contributed or led to the event were reported.It was stated that the lead was stretched out due to set screw, the surgeon squeezed lead contacts back together and the issue was resolved at the time of the event.The surgeon recommended change of design to include more set screws or have it be at the opposite end.The surgeon was frustrated as a letter did go out about this issue, but they did not feel like the guidance did resolve the issue.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

Information references the main component of the system and other applicable components are : product id 3389s-40 lot# va1q1sr serial# implanted: (b)(6) 2018 explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) indicating that the surgeon felt that the cause of the stretched lead was due to the set screw on the boot.

• 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: 7874325
• MDR Text Key: 120879775
• Report Number: 3004209178-2018-20616
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Date Device Manufactured: 05/18/2018
• 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 Age: 64 YR