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

Model Number 37602

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Paralysis (1997); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported there was a shocking or jolting sensation.It was noted the patient felt ¿paralyzed in their leg¿ the day prior to report.It was noted they felt ¿paralyzed in their arm and shocking¿ since the implant.It was noted the patient had fallen on (b)(6) 2013.It was stated they had fallen and broken their hip.It was noted the patient had not done well since the fall.It was noted the paralyzed feeling in their leg had not gone away.It was stated their arm would go paralyzed for 8 seconds and then it would stop.It was noted the patient had seen their doctor the week prior to report and no adjustments or changes were made to the dbs settings.It was noted they had requested to not have the dbs raised because it would cause a shocking sensation and it would paralyze them.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387-40, lot# l54554, implanted: (b)(6) 1998, product type: lead.Product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1998, product type: extension.(b)(4).

Event Description

Additional information received reported the cause of the event was too much voltage.It was noted there were no abnormal impedance measurements.It was noted reprogramming was performed 19 days prior to report.It was stated the patient did not require hospitalization and there was no injury or illness and the patient recovered without sequelae.It was noted the patient seldom operated the deep brain stimulator (dbs) as they did not want to waste the battery.

• 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: 3734588
• MDR Text Key: 4329528
• Report Number: 3004209178-2014-05812
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2014
• Date Device Manufactured: 04/04/2012
• 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): Other
• Patient Age: 00085 YR