MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Intermittent Continuity (1121); High impedance (1291); Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturer representative (rep) reported that the patient has been complaining of feeling an intermittent tingling sensation at the pocket site when they turn their head to the right side, with it noted that it is the right sc for vim.Electrical impedances were checked with the patient turning their head to the right with the following out of range: c0 = 2476, c1 = 2264, 01 = 3531, 03 = 3514, 13 = 3244, with the patient programmed at c+ 2- 2v/60pw/130hz.No tingling sensations occurred when impedances were checked.However, when the pocket site was pressed and the patient's head was turned to the right, they felt a tingling sensation in their left hand with the following high impedances: c0 = 2493, c1 = 2271, 01 = 3559, 02 = 2767, 03 = 3514, 13 = 3244.The last episode for the patient was on (b)(6) 2016, and follow up with the healthcare provider (hcp) is to be conducted.On nov-15 the rep confirmed the tingling was present for 1-2 seconds and then diminished and did not come back.The cause of the intermittent tingling was because they were doing an impedance check on the right lead at 3v causing the side effect for the patient.The tingling sensation resolved almost immediately after the patient mentioned it and it was gone.The patient's indication for implant is essential tremor.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6142566
• MDR Text Key: 61403844
• Report Number: 3004209178-2016-25078
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Date Device Manufactured: 10/06/2014
• 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