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

Model Number 37603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient had unilateral lead placement to control tremor with good response initially.It had been observed that after 4 to 6 weeks, the patient experienced ¿rapid habituation¿ of the current, and their tremor returned within 4 days and it was ¿to the same extent that it was prior to the device¿ but ¿not as bad as the refractory tremor.¿ this had reportedly been a ¿constant cycle¿ and became a concern as the patient reached 6v in bipolar mode and "bordered on" the patient experiencing a ¿capsular effect.¿ this ¿capsular effect¿ was clarified to mean ¿voice, speech, double vision as well as a hot and cold sensation.¿ other experiences that had increased since having the device included tremor, inbalance, headache, arm aching, ¿clammy hands¿, contracture of the hand, exhaustion from tremor and inability to hold cutlery.It was also noted that when the patient¿s device was turned off, he had a ¿severe¿ refractory tremor, far worse than it was prior to the device.This was ¿so violent¿ that it could only be turned off for a minute.There had been no falls or trauma prior to noticing this.The physician feared that it could be morphology of the disease.The reporter indicated that initial thresholding was done but electrode configuration had remained the same at a setting of 90's, 130 hz on electrode pair 0-,1+.The amplitude had been increased from 2.2v to 6.4 in several increments.Threshold testing had been performed again, but to no avail.All electrode and therapy impedances were normal for all testing done with the patient in a rested position, arms up and head to the side.Additionally, no error messages had been observed on either the clinician or patient programmers.The patient was admitted to the hospital for further tests and was placed on constant current mode at 4.6a under observation.A ct scan was performed which showed ¿perfect lead placement within the proposed target.¿ the patient had also undergone ¿some more testing¿, details of which were not available at the time of the report.The patient had however not had any ¿positive change¿ yet.Discussions about the possibility of creating a "lesion effect" with the lead were underway.The reporter stated that the implantable neurostimulator (ins) was going to be replaced.If additional information becomes available, a follow-up report will be submitted.

Manufacturer Narrative

Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3387-40, lot # 0208456401, implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 4334699
• MDR Text Key: 5220078
• Report Number: 3004209178-2014-24082
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Date Device Manufactured: 02/22/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention