MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 05/15/2014

Event Type  Injury  

Event Description

It was originally reported on (b)(6) 2014 that the patient fell on the day of the report and hit her back on the edge of a table.The area was really tender and the patient was going to go to urgent care and wanted to check if she could have an x-ray.The patient noted that it was not due to her device or therapy, but due to her parkinson¿s.The patient had a tendency to fall every once in a while without knowing she was going to.About two and a half weeks later it was reported that the patient still had concerns regarding her device or therapy but was working with her doctor or manufacturer representative.The patient listed an appointment for (b)(6) 2014.About three weeks later it was reported that the patient had an increased number of falls since implant.The patient noted that she was falling even before implant, but the falls tended to be more controlled and ¿softer.¿ the patient stated that before she would ¿just get bruises¿ and was now falling twice as much.The patient thought it may be even in the wake of turning on the implantable neurostimulator (ins) a month after implant.The patient had a fall at easter time.The patient then had a fall on (b)(6) 2014 and two in the ¿last week.¿ one when the patient was coming in the door, stubbed her foot, and fell and hit her rib.The patient was diagnosed with a cracked rib.The patient then fell again on (b)(6) 2014 and fractured vertebrae l1 by ct analysis at an emergency room (er).At the time of the report the patient fell flat on her behind while standing in the kitchen.The patient was uncertain if she was bending over and noted her dog was there, so she really was unsure how that fall happened.The patient had been on pain medication since the fall and went out and did some yard work the day prior and that seemed to aggravate things.The cause of the event seemed to be temporally related to the surgery.It was a brand new battery, no depletion, and no issues with the lead or extension.It may be worse since turning on the ins and programming, so the patient was asked to turn off the ins and come in for reprogramming on (b)(6) 2014.The patient was also asked to use adaptive equipment to prevent falls, specifically a cane or walker.The patient had an injury and was in recovery, non-life-threatening, but clearly at risk for more falling and there was concern regarding her balance and gait and potential for future falls and injury.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # va0f6ng, implanted: (b)(6) 2014, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3389s-40, lot # va0f6ng, implanted: (b)(6) 2014, product type lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3915421
• MDR Text Key: 19967101
• Report Number: 3004209178-2014-12569
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2014
• Date Device Manufactured: 11/12/2013
• 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): Other
• Patient Age: 00072 YR