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 Dysphasia (2195); Complaint, Ill-Defined (2331); Eye Burn (2523); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient was left in a nursing home, worse off.Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home.The patient could barely feed himself.The patient had gone through the surgery wide awake ¿like a trooper.¿ it had all gone downhill about 2 months after the deep brain stimulator surgery.The patient had good progress after the surgery for a week to a week and a half or two weeks.The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home.The patient could not talk , walk or feed himself.The patient¿s system was checked two years prior to the date of this report.Patient¿s status was unknown.Reprogramming had been tried.The patient had been his healthcare professional¿s and still could not walk or talk.

Event Description

It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast.The patient could not text.

Event Description

It was reported the patient got worse after surgery.The patient was diagnosed with parkinson¿s disease over the years prior to this report.The reporter stated the surgery did nothing for the patient.Additional information received reported that the patient had great results for two weeks.However, at the time of the report he was confined to a nursing home, where he could not walk, talk, or even make a phone call.

Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead.Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Manufacturer Narrative

(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: 4762647
• MDR Text Key: 5780747
• Report Number: 3004209178-2015-08838
• 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,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Date Device Manufactured: 04/19/2012
• 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): Disability
• Patient Age: 00054 YR