MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Discomfort (2330)

Event Date 02/07/2017

Event Type  Injury  

Event Description

Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the implantable neurostimulator (ins) migrated and rotated several times.It was also noted that the patient experienced tenderness over the ins site.The diagnostic methods included an examination on (b)(6) 2017 that resulted in the identification of the issue.X-rays were also performed on the same day that resulted in an interval revision of the bilateral deep brain stimulators without pneumothorax; the patient's lungs appeared clear.The etiology was noted as related to the device/therapy and unlikely related to the implant procedure; the implantable neurostimulator (ins) was noted.The action/interventions taken to resolve the issue included repositioning the ins on (b)(6) 2017; the event was considered resolved without sequelae.It was also noted that the event resulted in an unscheduled clinic or office visit.No further complications were reported/anticipated.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 6572785
• MDR Text Key: 75361773
• Report Number: 3004209178-2017-10485
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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: 09/14/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 05/15/2017
• Supplement Dates FDA Received: 10/04/2017
• Date Device Manufactured: 03/17/2016
• 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
• Patient Age: 53 YR