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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Pocket Erosion (2013)

Event Date 10/15/2014

Event Type  Injury  

Event Description

It was reported the patient presented to the emergency room after sustaining a fall outside their home which resulted in wound dehiscence and exposed stimulator and extensions.The stimulator and extensions were immediately removed and replaced.The etiology was the stimulator pocket and was noted as not related to the device, therapy, or implant procedure.The event resulted in in-patient hospitalization and required surgical intervention.The event was considered resolved without sequelae.

Manufacturer Narrative

Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va0l1c8, implanted: 2014 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0l1c8, implanted: 2014 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2014 (b)(6); 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: 4508511
• MDR Text Key: 5408502
• Report Number: 3004209178-2015-02849
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Date Device Manufactured: 06/11/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 00065 YR