MAUDE Adverse Event Report: MEDTRONIC B.V. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37604

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

Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994); Concussion (2192); Convulsion/Seizure (4406)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 0913025, lot#: s3703-02, implanted: (b)(6) 2020.; product id: 3708760, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.; product id: 3708760, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.Product id: 0913025, serial#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that at 8am in the morning the patient wanted to go downstairs but fell down the stairs.They had a lot of seizures during the night.Due to a lot of pain the patient went to the hospital for an x-ray of the ribs and ct scan.They had a concussion and bruised ribs.No additional interventions or actions were taken, but the issue wasn't resolved.Additional information was received: it was reported that had seizures during the night, that was why the patient woke up and went downstairs.They had another seizure while they were on the stairs and that caused the patient to fall.They only went to the hospital for imaging of their brain and ribs.There were no further actions/interventions taken other than the device being checked, and impedances were still normal with no stimulation problems found.The patient was still healing, but no action needed to be taken.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC B.V.; earl bakkenstraat 10; heerlen 6422 PJ; NL 6422 PJ
• Manufacturer (Section G): MEDTRONIC B.V.; earl bakkenstraat 10; heerlen 6422 PJ; NL 6422 PJ
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14844584
• MDR Text Key: 295117309
• Report Number: 3002807561-2022-00013
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37604
• Device Catalogue Number: 37604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2022
• Date Device Manufactured: 11/09/2018
• 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