MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problem Unintended Collision (1429)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/26/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 64002, lot# n363643, implanted: (b)(6) 2014, product type: adapter.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3389s-40, lot# v067936, implanted: (b)(6) 2008, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3389s-40, lot# v386123, implanted: (b)(6) 2010, product type: lead.(b)(4).

Event Description

Information was received from the patient that reported they had fallen and could hardly move their arm.The patient had an x-ray and it was not broken.The patient was implanted for dystonia and movement disorders.Further follow-up is being conducted to determine what actions/interventions were taken and what the cause of the fall was.If additional information is received a follow-up report will be submitted.Please see manufacturer report #3004209178-2015-21474 for information on the patient's concomitant system.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 5179060
• MDR Text Key: 29939614
• Report Number: 3004209178-2015-21475
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2015
• Date Device Manufactured: 11/08/2012
• 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 Age: 00045 YR