MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported there was a shocking or jolting sensation.It was noted patient had left internal global pallidus (gpi) for dystonia.It was stated they had an intermittent shocking sensation to their right arm from their elbow down to the fingers.It was noted it began one week prior to report and it continued to happen.It was noted when the implantable neurostimulator (ins) was turned off they still felt some shocking in their right arm.It was stated twice they felt shocking at the ins pocket site on the left side.It was noted when they used a hand dryer in a public bathroom they felt shocking in their right arm.It was noted they met with their clinician on the day of report to check the system.It was stated the impedances were fine and the ins and extension were palpated and no issue was observed.It was noted the group usage said 10% on the first page and 100% on another page of the clinician programmer printout.It was noted the patient would begin to log the events to help the health care professional determine the issue.

Manufacturer Narrative

Concomitant products: product id 64002, lot# n217529, implanted: (b)(6) 2010, product type adapter; product id 748240, serial# (b)(4), implanted: (b)(6) 2002, product type extension; product id 37092, lot# 243250001, implanted: (b)(6) 2010, product type accessory; product id 37651, serial# (b)(4), product type recharger; product id 37642, serial# (b)(4), product type programmer, patient; product id 3387-40, lot# j0120724v, implanted: (b)(6) 2002, product type lead; product id 3550-09, serial# (b)(4), implanted: (b)(6) 2007, product type accessory.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 3888969
• MDR Text Key: 4673473
• Report Number: 3004209178-2014-11937
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2010
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• Date Device Manufactured: 09/15/2009
• 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: 00057 YR