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

Model Number 37603

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

Patient Problem Shaking/Tremors (2515)

Event Date 06/29/2015

Event Type  Injury  

Event Description

It was reported there was lead migration.Surgical intervention was required as a result of the event and it was replaced with a new lead and new ¿stim¿ cap.The issue was resolved.The cause of the issue was determined ¿ the stimloc ¿pac-man¿ slipped and didn¿t lock in place which caused the lead to move.The patient didn¿t have tremor control and they had tremor in their right hand.Their status at the time of report was alive with no injury.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va0urxw, explanted: (b)(6) 2015, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4919648
• MDR Text Key: 16162629
• Report Number: 3004209178-2015-13549
• Device Sequence Number: 1
• Product Code: MHY
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Date Device Manufactured: 03/25/2015
• 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: 00084 YR