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

Model Number 37612

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

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Paresis (1998)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient experienced right hemiparesis and stupor associated with hypertension.The etiology was considered related to implant procedure and hypertension.Diagnostic imaging showed small thalamic hemorrhage toward the inner left capsule.Examination revealed neurological deterioration (stupor and hemiparesis).Infusion of sodium nitroprusside at 1.5 mcg/kg/min was administered.The event resulted in prolonged hospitalization.The event resolved as of (b)(6) 2015 without any sequelae.

Manufacturer Narrative

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

Event Description

Additional information was received indicating hypertension is a pre-existing medical condition of the patient.It was reported the patient had small hemorrhage thalamic and toward the inner left capsule, which was determined to be related to surgery/anesthesia.The issue resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.The issue was resolved with subtle paresis in the upper right limb.

Manufacturer Narrative

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

Event Description

Device information was received.It was stated the event was related to the lead implant procedure.

Manufacturer Narrative

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

Event Description

Additional information was received indicating the issue was unresolved with no further action planned.The patient was hospitalized in the intensive care unit on (b)(6) 2015 and had medical or non-surgical therapy, with medications administered, which were nitroprusside, continuous intravenous infusion.This resulted in permanent impairment of a body structure or body function, required in-patient or prolonged hospitalization, and resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9387487
• MDR Text Key: 173451037
• Report Number: 3004209178-2019-22799
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/28/2019; 01/02/2020; 04/16/2020
• Supplement Dates FDA Received: 12/12/2019; 01/17/2020; 04/19/2020
• Date Device Manufactured: 06/30/2015
• 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): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 53