MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pocket Erosion (2013)

Event Type  Injury  

Event Description

It was reported that on monday prior to the date of this report the patient had hit one of his generators with his car door and it had become exposed.A picture was taken and you could see the generator protruding through the skin.The generator was explanted on monday prior to the date of this report.No diagnostic testing or troubleshooting was done.The issue was not resolved.The patient was alive with no injury.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 3004209178-2014-22812.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3387s-40, lot# va0k331, implanted: (b)(6) 2014, product type: lead.Product id: 3708660, serial# (b)(4), implanted: 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information received had indicated that the issue only involved the right side device.Any additional information received will be reported via manufacturer's report number: 3004209178-2014-22812.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4307687
• MDR Text Key: 5129889
• Report Number: 3004209178-2014-22813
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Date Device Manufactured: 04/30/2014
• 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): Required Intervention
• Patient Age: 00052 YR