MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient had a new device placed two weeks prior and the patient is feeling it like a very warm heat in their head.It was reported as heating of dbs lead in the patient's head.There was no fever present.The patient feels like +45 celsius in their head.No infection rate was seen, but the patient was given antibiotics.The patient is set at 1.85v.The patient feels as if treatment isn't there at all.No further complications were reported or anticipated.

Manufacturer Narrative

Device used for off label indication.The indication the device was used for was dystonia.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturing representative.It was reported that the patient was implanted for dystonia.There were no out of range impedances measured.The patient's settings are 1.85 v, 450 us and 130 hz on both the left and right side.

Manufacturer Narrative

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

Event Description

Additional information received on dec-13 stated that the patient experienced a fall in the street after ins was implanted.The burning sensation only occurs when stimulation is above.9 v and goes away after the ins is turned off for around 30 minutes to 1 hour.The heating sensation in the middle of the head but goes to the whole brain.The patient stated it feels like the brain is cooking and that they have a fever.Palpating the system does not cause the sensation.The cause has not been determined.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturing representative.It was reported that the heating sensation is gradual and comes and goes over hours.The hcp was going to perform an x-ray to check the connections, adjust stimulation and perform a placebo test.It was further reported on dec-13 that the patient was now feeling electrical sensations every 4-5 minutes in the left axillar area, up on the left neck and to the lower jaw and over the middle breast bone.It was stated the patient was also implanted for torticollis.The patient's therapy was adjusted from.9 v to 1.1 v.The patient again felt the burning in their head so stimulation was adjusted to.8 v.The x-ray showed no anomalies with the device, and the placebo effect test showed that the patient was feeling the sensation.At.8 v the patient did not experience the sensation, but therapy was not sufficient.It was stated the patient was very bad on medication so they need therapy.The patient previously had very good success with therapy, and the x-ray confirmed the leads were in the same location.The infection after ins implant was confirmed, however the infection rate is back to normal.The patient was experiencing a shocking sensation.Further information was received dec-15 stating the patient stopped feeling electrical sensations every 4-5 minutes.The patient is instead now feeling electrical sensations on the left side when changing positions.The patient's hcp is not interested in performing another operation on the patient's system at this time.

Manufacturer Narrative

Product id: 3389, serial# unknown, product type: lead; product id: 3389, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information indicated the patient was implanted in the left and right internal globus pallidus (gpi).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7076532
• MDR Text Key: 93519387
• Report Number: 3007566237-2017-05028
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H020007
• 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,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• Date Device Manufactured: 06/01/2017
• 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