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

Model Number 37603

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fatigue (1849); Muscle Spasm(s) (1966); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Electric Shock (2554)

Event Date 01/21/2016

Event Type  Injury  

Event Description

Information received from a clinical patient reported the patient experienced a stroke after the physician turned their device on/off on (b)(6) 2015.The physician was ¿turning the stimulation on and then it gave [the patient] a stroke, not they didn't turn it on they turned [the device] off and they gave [the patient] a stroke.¿ indications for use included dystonia and movement disorders.See manufacturing report 3004209178-2016-27100.

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.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: implantable neurostimulator.(b)(4).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

Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep).It was reported that the health care provider (hcp) has no records or knowledge regarding an appointment on (b)(6) 2015.It was noted however, that the patient had a visit on (b)(6) 2016 and reported that on the day prior, the patient and their spouse were adjusting the deep brain stimulation (dbs) and it caused a spasm in the patient's left arm and face that lasted for about 45 seconds before completely resolving.There was some concern that this represented a stroke or tia, but it occurred precisely at the time that the dbs was restarted.An mri of the patient's brain was performed, but no abnormalities were found.The hcp's assessment/synopsis was noted as: the patient's nih stroke scale/score (nissh) was very low, their symptoms are rapidly improving and their neurologic exam is more consistent with alcohol than stroke.The hcp also noted that they would check urine drug screen (uds) and ethyl alcohol (etoh) levels as the patient appeared intoxicated.A ct scan of the patient's head and a ct perfusion were performed and showed an unrelated long segment of complete occlusion of the right vertebral artery with reconstitution as well as apparent perfusion defect involving the left anterior mca territory surrounding the brain stimulator, which could be artificial.The final diagnosis included an altered mental status and alcohol intoxication.The patient's discharge diagnosis on (b)(6) 2016 included "altered mental status, resolved".Another follow-up appointment was conducted on (b)(6) 2016 where the patient presented with two spells.The first spell was related to deep brain stimulation (dbs) in that when the device is suddenly turned on, the patient gets a "jolt" and "can have drawing of the face".The hcp stated that they feel this is expected and is not indicative of tia.The second spell was noted to be likely related to the alcohol, fatigue, and a fall; the hsp did not think either spell was a tia or stroke.However, the hcp noted that they thought the new vertebral artery occlusion was most likely due to an unrelated atherosclerosis, as there was "some plaque seen at the origin of vert on the right and then is occluded".The hcp thought the patient was at risk for stroke and felt that the patient should continue asa and statin.The patient's medical history included: hyperlipidemia, bipolar, and pseudoseizures and dystonia.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6200404
• MDR Text Key: 63174320
• Report Number: 3004209178-2016-27101
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2017
• Date Device Manufactured: 06/16/2015
• 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: 51 YR