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

Model Number 7428

Device Problem Malposition of Device (2616)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Muscle Weakness (1967)

Event Date 06/15/2013

Event Type  Injury  

Event Description

It was reported, the patient had been implanted on (b)(6) 2013 to treat parkinson's disease.On (b)(6) 2013, the patient went to the hospital for reprogramming due to "leg ache and weakness", and difficulty to take a step and falling down easily.It was reported on (b)(6) 2013, the patient fell down and fractured a hip, so the patient went back to the hospital for treatment.It was reported, the patient had a limb tremble on (b)(6) 2013, and went back to the hospital for reprogramming and that improved the symptom (limb tremble).It was noted the difficulty taking steps and falling down easily were not improved.It was reported, the patient's health care provider (hcp) indicated the target spot "deviation by mri checking".Additional information reported it was unknown if the patient had any further troubleshooting done.

Manufacturer Narrative

(b)(4).

• 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: 3611043
• MDR Text Key: 4155634
• Report Number: 3004209178-2014-01701
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Date Device Manufactured: 02/24/2012
• 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): Other
• Patient Age: 00069 YR