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

Model Number 37602

Device Problem Pocket Stimulation (1463)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Type  malfunction  

Event Description

It was reported that the patient felt a tingling at the implantable neurostimulator (ins) site in their left chest.It was unknown if therapy had been titrated down at implant as suggested due to differences in voltage between legacy and current devices.Threshold testing had not been redone.Imaging had not shown any visible issues with the system.The issue was unresolved at the time of this report and the healthcare professional planned to address the tingling problem surgically, but they had since decided to do no intervention at the time of this report.Impedances of the left globus pallidus (gpi), right abdomen placement and right gpi, left chest subclavicular placement were run at 0.7 and 3.0v.All impedances were within normal limits.Follow up with the patient healthcare professional (hcp) indicated that the cause of the event was not determined and it was unknown if it was device related.X-rays and reprogramming was done.No intervention or outcome was provided regarding the event.Further follow-up is being conducted to obtain this information.

Manufacturer Narrative

Concomitant products: product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator; product id 3387s-40, lot# v679192, implanted: (b)(6) 2011, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type extension; product id 3387s-40, lot# v679192, implanted: (b)(6) 2011, product type lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2011, product type extension; product id 7438, serial# (b)(4), product type programmer, patient; product id neu_ins_stimulator, serial# unknown, product type implantable neurostimulator.(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: 4218234
• MDR Text Key: 5075371
• Report Number: 3004209178-2014-20781
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 10/31/2014
• Date Device Manufactured: 03/21/2013
• 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