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

Model Number 37601

Device Problems Intermittent Continuity (1121); Unintended Collision (1429)

Patient Problems Therapeutic Response, Decreased (2271); Dyskinesia (2363); Ambulation Difficulties (2544)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 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: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead.Product id: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead.(b)(4).

Event Description

The patient reported that she fell on (b)(6) 2015 and hit her head and pelvis.After the fall she had trouble moving and an intermittent return of dyskinesias.This was considered a sudden issue.The implantable neurostimulator (ins) was on and ok.She had an appointment to see her healthcare provider (hcp) on (b)(6) 2015.The patient's indications for use were parkinson's dual and movement disorders.No intervention or patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Event Description

Additional information from the consumer reported they notified their physician about the dyskinesia but the dyskinesia's have gone away.The patient had been using their walker all the time and went to physical therapy to improve balance as the steps to resolve the difficulty moving and intermittent dyskinesia symptoms.

• 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: 5024831
• MDR Text Key: 24780349
• Report Number: 3004209178-2015-16557
• 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
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Date Device Manufactured: 11/18/2011
• 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 Age: 00081 YR