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

Model Number 37602

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Additional information received reported the event was ¿incorrect.¿ it was stated there were no revisions or surgical interventions at that time.It was stated there were no signs or symptoms at the time of report.It was unknown if the patient had required hospitalization.It was noted they managed the patient.

Event Description

Additional information received reported the previous follow up did not contain page 2.Therefore, it was stated there were no abnormal impedance measurements and there was no event.

Manufacturer Narrative

Product id: 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension.Product id: 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3387-40, lot# j0337577v, implanted: (b)(6) 2003, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension.(b)(4).

Event Description

It was reported the patient had stimulation in the wrong location.It was noted the patient had a magnetic resonance image (mri) of the head on the day of report due to lead placement.It was stated the right implantable neurostimulator¿s (ins) left lead implant had not been turned on for some time and the duration was unknown.It was noted it ¿made them crazy.¿ it was stated the settings were too high and the doctor wanted to remove the wire and put another one in.It was noted the lead was implanted in the wrong location of the brain.It was stated they had not interrogated or checked the impedances on that side at the time of report.It was noted the patient also had an x-ray to confirm that the wires did not cross over the chest area.Additional information received reported the ¿lead had never worked from the beginning.¿ it was stated there was no problem with the impedance measurements.It was noted the patient had used the lead sometimes but not for long.It was noted the patient had good control of their tremor from the right lead.

• 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: 3739542
• MDR Text Key: 4497186
• Report Number: 3004209178-2014-05994
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2014
• Date Device Manufactured: 06/07/2011
• 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