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

Model Number 37603

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported the patient had a loss of therapeutic effect.The patient had the implantable neurostimulator (ins) in their upper left chest for the right side of their body.For the last couple of days the patient¿s right arm had been shaking.The reporter stated the implant near the right collar bone did not work because it was in the wrong spot in the patient¿s brain so it did not work.It had not worked for a while so it was not on.The reporter stated they put it in the wrong spot in the brain.The ins was on and there was no known accident or incident related to this complaint.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, the event will be updated.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # va08kln, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, product type lead; product id 7438, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v233444, implanted: (b)(6) 2010, 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: 4377933
• MDR Text Key: 5287027
• Report Number: 3004209178-2015-00065
• 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
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2014
• Date Device Manufactured: 05/24/2013
• 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: 00077 YR