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 Problem Dysphasia (2195)

Event Type  Injury  

Event Description

It was reported that there was a stimulation/therapy issue, patient was complaining of sudden speech slurring.The action required as a result of the event was reprogramming and hospitalization.No diagnostic testing or troubleshooting was performed but would be in the future.It was unknown if the issue was resolved or if the cause of the issue was determined.Patient had a sudden increase in slurring of their speech and had gone to the hospital.The hospital tests had come back negative.Patient¿s husband wanted to lower stimulation and lowered both sides by about 1 volt, the patient had tolerated this well.Two hours after the change the patient was doing fine and had been released from the hospital.A follow-up visit was being scheduled to check impedances and reprogram if necessary.The patient was alive with no injury.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3389s-40, lot# va023l5, implanted:(b)(6) 2012, product type: lead.Product id: 3389s-40, lot# va08klm, implanted: (b)(6) 2013, product type: lead.(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: 3936108
• MDR Text Key: 15363586
• Report Number: 3004209178-2014-13042
• 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
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2014
• Date Device Manufactured: 08/02/2012
• 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): Hospitalization
• Patient Age: 00079 YR