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

Model Number 37602

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Event Description

It was reported that the patient was unable to adjust stimulation.It was also reported that the patient was experiencing freezing, loss of reflexes, and couldn¿t move her body at times.The symptoms were worsening.The patient also had a swollen foot.The patient¿s neurologist told them the stimulation frequency needed to be decreased by (b)(6), but the patient¿s daughter was not comfortable adjusting the stimulation.It was also noted that right after implant in (b)(6) ¿they just cranked it up and that was it.¿ the patient was scheduled for an appointment with their health care provider on (b)(6) 2015.The patient was waiting for a company representative to be present to help program her device.It was reported a month later that the patient saw her doctor two weeks ago and that she did not have an appointment on (b)(6) 2015.The doctor commented that the patient does not seem to take their advice including ¿wrt¿ medications.The patient did not have additional surgery but was waiting to have surgery done.The doctor did not feel that there was much a company representative could do.No additional follow up information was available.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

• 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: 4860153
• MDR Text Key: 17932757
• Report Number: 3004209178-2015-12003
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2015
• Date Device Manufactured: 01/28/2014
• 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