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

Model Number 37612

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported the lead had moved and the patient had less than 50 percent therapy relief.Following the stage one implant procedure, the lead was in good position.After the stage two implant procedure, it was noted the lead had moved.Mri and x-rays were done.During the lead removal, the healthcare professional (hcp) noted the lead was not perpendicular to the stimloc clip as it should have been.A new lead was implanted and the issue was resolved.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# va0sa86, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 37612, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v603031, implanted: (b)(6) 2011, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension; product id neu_stimloc_acc, serial# unknown, product type: accessory.(b)(4).Analysis of the lead (lot # va0sa86) found the body of the lead was cut through and the product was segmented.

• 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: 4778331
• MDR Text Key: 5856059
• Report Number: 3004209178-2015-09295
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

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: 10/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/18/2015
• Date Device Manufactured: 11/17/2014
• 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