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

Model Number 37603

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Malposition of Device (2616)

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

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative about a patient with an implantable neurostimulator (ins) for dystonia.It was reported that the patient had high impedance on the right lead.The patient's lead was explanted and replaced.An x-ray of the system showed the connector was placed in the mastoid region, almost in the patient's neck.After lead replacement the impedance was fine.The patient is receiving effective therapy.It was unknown if there were any external or environmental factors that led to the event.No further complications were reported or anticipated.

Manufacturer Narrative

Implanted: explanted: (b)(6)2018 product type lead.Device code (b)(4) has been replaced with (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from a health care provider (hcp) via a manufacturer representative (rep) clarified the lead/extension connector was suspected to have migrated.No further complications were reported/anticipated.

• 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: 7454717
• MDR Text Key: 106304704
• Report Number: 3004209178-2018-08688
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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: 05/28/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/11/2018
• Date Device Manufactured: 12/02/2016
• 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