MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_ext, serial# unknown, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator parkinson's disease.It was reported that there was a suspected fracture associated with the right side of the deep brain stimulation (dbs) system; there was an issue with the extension.The cause and if there were any environmental/external/patient factors that may have led or contributed to the issue were stated to be unknown.The actions/interventions taken to resolve the event including scheduling an implantable neurostimulator (ins) and extension explant on (b)(6) 2018.The event remains ongoing at the time of this report.No further complications were reported/anticipated.

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_ext, serial# unknown, explanted: (b)(6) 2018, product type: extension; product id: 3387, lot# unknown, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).It was confirmed that the reason for the implantable neurostimulator (ins) removal was due to battery replacement.The rep then reported that the replacement procedure occurred on (b)(6) 2018.During the procedure, the ins and adaptor were replaced.Impedances were checked on the lead alone and due to the values remaining high, the lead was also replaced with a new device.It was also noted that the serial/lot numbers of the devices were unknown as the facility discarded the devices.There was no known impact or consequence to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturing representative (rep) indicated the lead was responsible for the suspected fracture.There was no issue with the ins.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7503963
• MDR Text Key: 107904092
• Report Number: 3007566237-2018-01411
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 05/15/2018; 05/16/2018
• Supplement Dates FDA Received: 05/16/2018; 05/31/2018
• 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): Required Intervention