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

Model Number 7428

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

Patient Problems Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the device was implanted on (b)(6) 2013 and right after implant the patient lost functionality.The patient was able to walk with help but was not able to use his hands to eat, could not turn over in bed and could not move himself.The patient had physical and occupational therapy and had regained 30-40% of his functionality.The patient took a lot more sinemet orally.The issues had continued until the patient had a revision.Reference manufacturer¿s report number: 3004209178-2015-09174.

Manufacturer Narrative

Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).Reference report number: mw5041381.

Event Description

It was later reported that the day following the patient's new implant his ability to function had taken a nose dive.The patient had been functioning extremely well, even driving a car with his previous device.Following the new device he felt very weak and ill for a day.The night following that day the patient had woken up unable to move much, he was extremely disabled.The patient's wife had to walk him to the bathroom, help him with his needs there and bath him.The patient's speech had worsened and he was unable to walk without help.The neurosurgeon was made aware and had stated that he could not explain how that would be related to the deep brain stimulator device.The patient was still functioning poorly but due to physical therapy he could walk with a walker and feed himself.The patient's change in function had basically been dramatically overnight and had taken a month of home healthcare to get the patient back to half the function he had before the new device.The patient had never returned to previous functioning levels.

• Brand Name: KINETRA
• 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: 4774612
• MDR Text Key: 15346539
• Report Number: 3004209178-2015-09188
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Date Device Manufactured: 07/30/2008
• 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; Disability
• Patient Age: 00072 YR