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

Model Number 37612

Device Problem High impedance (1291)

Patient Problem Pain (1994)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37651, serial# (b)(4), product type: recharger.Product id: 8840, product type: programmer, physician.

Event Description

The health care provider (hcp) reported via the company representative (rep) that the patient recharged well in the hospital following device implant.During the patient's first "at home" recharging session since implant, after approximately 5 minutes the recharger went blank, stopped recharging, and started to beep continuously.The patient had pain on the right side of his head at that moment.The patient was unable to continue recharging.The patient has four leads implanted and programming occurs via use of an xbo application card (custom made).The patient was used to being programmed on all four leads.When the nurse tried to check the device it asked for the access code again but she was not able to get the clinician programmer to accept the code.Numerous attempts were used with clinician programmers.The nurse was not able to communicate with the implantable neurostimulator (ins).The nurse could see that the device was switched on and the patient was receiving therapy.It was unclear if the patient's symptoms were as well controlled as before, as the nurse had never followed the patient before.The patient did not want the battery to be switched off as he has balance issues without therapy.The nurse was not able to communicate with the ins so no additional testing or checking current settings were able to be performed.It was unknown if there were any external factors that may have contributed to the issue.Troubleshooting was performed, the patient attended the clinic on (b)(6) 2016 and was issued a replacement recharger and sent home.The patient was recharging well now.The issue was not resolved at the time of this report.It was noted that the rep was instructed to reset the recharger.No surgical intervention occurred, unknown if planned.The patient was alive with no injury.It was also reported that there were out of range impedances: c & 4 2,050ohms.It was additionally reported that the patient has been previously programmed using an xbn card with the previous ins.The xbn card and old access code were used to attempt programming by the surgeon.The surgeon was unable to unlock the card/device as the old access code was used with a xbn card.The xbn software does not store a correct access code, therefore, when the surgeon did the programming with the xbn the access code was not saved or remembered on this card.A week after the initial report the patient reported to their nurse that the recharger was not holding its charge at all now.There was an error sign on the recharger, unclear what.The patient continued to have pain on the right side of his head since the recharger issues.When the doctor pressed on the area the pain didn't get any worse.The ins was able to be interrogated with an xbn card and the new access code.The ins was turned off completely and the pain in the patient's head disappeared.Then turned on each electrode "off" one by one to assess effects.Lead one c+-1-2 had most effect so was switched off.The patient still had some pain but it was more bearable.The patient was able to start a recharge no problem with the replacement recharger.Eight days later the rep reported that the recharger was reset.The pain on the right side of the head did not fully resolve, reprogramming provided some relief.The patient was going to use the new recharger and inform the nurse of further issues.An appointment was going to be made for the patient to see the neurosurgeon for follow up.The indication for use included generalized dystonia.

Manufacturer Narrative

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

• 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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5691619
• MDR Text Key: 46296664
• Report Number: 3004209178-2016-10663
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2016

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: 12/14/2016
• 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: 05/04/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: 05/04/2016
• Supplement Dates FDA Received: 09/22/2017
• Date Device Manufactured: 01/27/2016
• 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: 61 YR