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); Cognitive Changes (2551)

Event Date 10/27/2011

Event Type  Injury  

Event Description

It was reported on (b)(4) 2014 that immediately after implant, the patient experienced erratic blood pressure and delirium.The patient had to be admitted to physical rehab and had to wear a ¿hospital-bed alarm¿ and was eventually ¿strapped to the bed.¿ the reporter stated that the patient¿s wife reported these issues to the hospital at the time.The reporter stated that the doctor seemed to dismiss the wife¿s claims, but it was only ¿second-hand info.¿ additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # v814474, implanted: (b)(6) 2011, product type lead; product id 3387s-40, lot # v814474, implanted: (b)(6) 2011, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2011, product type extension.The initial reporter was the patient's wife, but no name or information was provided.(b)(4).

Event Description

Additional information received reported that the reporter had not heard back from the patient.To the reporter¿s knowledge the cause of the erratic blood pressure and its potential relationship to the system was not determined.The patient was reported to be stable.

• 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: 3813619
• MDR Text Key: 4479079
• Report Number: 3004209178-2014-09055
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2014
• Date Device Manufactured: 09/13/2011
• 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; Other
• Patient Age: 00071 YR