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 Hemorrhage, Cerebral (1889); Muscular Rigidity (1968); Complaint, Ill-Defined (2331)

Event Date 01/22/2014

Event Type  Injury  

Event Description

Additional information received reported that the outcome resolved without sequelae on (b)(6) 2014.

Event Description

Additional information received reported that the event was related to the device or therapy and related to the implant procedure.

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# vaobuyn, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

It was reported that the patient experienced seizure like episodes.It was noted that the outcome was ongoing.It was noted that diagnostic methods included ct scan with contrast showing small amounts of blood around mid-portion of left dbs electrode.It was noted that the etiology was surgery/anesthesia.It was noted that the event was not related to the device or therapy.It was noted that the event was related to the implant procedure.It was noted that during the event the patient¿s armed flexed and began expressing gurgling sounds.It was noted that the ct reveled a small amount of blood around mid-portion of left dbs electrode in basal ganglia.It was noted that the severity was severe.It was noted that the event resulted in in-patient hospitalization.Additional information received reported that the seizure like episode occurred during the operating procedure.It was noted that the entire system was removed on (b)(6) 2014.Additional information received reported that the patient was having his system replaced when the event occurred.It was noted that the patient had not had the implantable neurostimulator (ins) placed yet.Additional information received reported acute hemorrhage around the left electrode.It was noted that after recovering the patient¿s implantable neurostimulator (ins) was implanted on (b)(6) 2014.It was noted that interventions included medical or non-surgical therapy including a regular textured diet.It was noted that the medical or non-surgical intervention was pharmacological.It was noted that eeg results were negative.It was noted that a ct scan with contrast showed that the patient was stable.

• 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: 3977510
• MDR Text Key: 4814726
• Report Number: 3004209178-2014-13916
• Device Sequence Number: 1
• Product Code: MHY
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Date Device Manufactured: 09/03/2013
• 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
• Patient Age: 00060 YR