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

Model Number 37612

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Muscle Spasm(s) (1966); Neurological Deficit/Dysfunction (1982); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event is an approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient was experiencing poor communication.Caller/patient's mother reports the entire system is not working.Caller says she does not know if patient needs the recharger (insr) or desktop charger (dtc).Caller reports the ins has not worked in awhile.Caller says the patient cannot charge the ins.She is not sure if he is able to charge the recharger.Caller reports the ins is dead since insr will not charge him.Patient was using it regularly and it quit working.Patient then got on the phone and had him use the recharger to confirm what screen it shows.Patient described getting re position antenna screen.Patient says the patient programmer is also not connecting.Patient just left the neurologist who told them patient needs to get a whole new system overnight.Caller says the healthcare provider checked the device and told them it was the equipment.Patient reported last charging session was more than one to three months ago, redirected to the healthcare provider to address possible overdischarge.Symptoms reported were ins is dead and not working.The patient was sent a replacement recharger to see if that resolves the issue but was redirected to their healthcare provider if it doesn't.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider indicating that it seems to be a device issue.The ins was placed 2 years ago, should last 9 years.The patient stopped charging 1-2 months prior to (b)(6) 2018 visit.No previous problems with charging it prior to that.Symptoms included worsening dystonia leading to muscle spasms, severe pain, syncope from pain, and 2 er visits from spasms and pain.The cause these issues was not determined.The system was checked by 2 providers in the clinic on (b)(6) 2018.Actions/interventions included having the system checked on (b)(6) 2018.There were no frayed wires, all connections tight.Patient brought his system to the clinic.The manufacturer was called to have a new system sent.The issue is not resolved.

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 por and recharger issues were resolved.The cause of the recharging issues was user error.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer via the manufacturer representative.The patient reported they received the replacement product on 2018-may-22.It was reported the battery was in over discharge and communication could not be established with either the patient programmer or the insr.It wasreported the patient was feeling stimulation but the last successful recharge was 2-3 months ago.It was reported the recharging was not maintained due to the recharging issues previously reported.The caller was instructed to continue recharging to 25% and clear the por.No symptoms were reported.The caller called back and stated the ins was between 25-50% charged and he tried to read it with the clinician programmer but was unable, noting to charge the battery.The caller was instructed on how to clear the por.

• 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: 7543318
• MDR Text Key: 109230982
• Report Number: 3004209178-2018-11853
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2018

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 Expiration Date: 07/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 06/26/2018; 06/29/2018
• Supplement Dates FDA Received: 06/06/2018; 06/28/2018; 07/06/2018
• Date Device Manufactured: 08/22/2015
• 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 Age: 30 YR
• Patient Weight: 67