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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); No Device Output (1435); Battery Problem (2885)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for parkinson's disease and dbs (deep brain stimulation) therapy indications.It was reported that the patient's ins recharger (insr) showed the ins was off.They were having a hard time charging the ins, and it was noted that since they were not able to charge the ins, that could be why stimulation was now off.The patient had no coupling bars filled when charging.On the call, they repositioned the antenna over the ins, turned the dial through all four positions, but were still not able to get any bars.The antenna locator (al) feature was attempted, but the insr showed the ins battery was low and needed to be charged.The patient had been having issues with the insr turning off every time they were charging as well.An email was sent to repair for replacement.Additional information indicated they received the new insr, but could still not turn stimulation on with it.It was reviewed the healthcare provider (hcp) may not have allowed the insr to turn stim on and off.The patient was never given a patient programmer (pp).They were advised to follow up with their hcp to get a pp and turn stimulation on.No patient symptoms or further complications were reported as a result of this event.Additional information was received reporting that they received the replacement recharger but they are still not able to turn stimulation on.They state it kept going blank intermittently, was not able to charge the ins, and that the ins is off.Caller added that the patient is now having a return of symptoms due to the ins being off, noting that it's to the point that the patient can't talk.Caller repeated that the patient received new recharging equipment and it shows 0 coupling bars, but reports getting 8 coupling bars at one point.They state the ins is now half full and is showing that the ins is still off.Caller confirmed that the patient's managing physician gave permission to turn ins on.They walked caller through activating antenna locate to turn ins on, and caller confirmed that they turned ins on successfully.Additional information was received from the patient on (b)(6) 2019.It was reported that the therapy was turning of by itself.Patient reported that this had happened before, the implant turning off and they are not sure why the implant is off.Caller stated patient was getting the ins full icon on the recharger screen but no thunderbolt.It was reported that therapy had been off and patient has been like a vegetable all weekend and it was getting worse and they needed the therapy turn back on.Patient called last month and was assisted them with turning therapy on.No reported patient falls/trauma.It was indicated that the ins battery charge was at 100%.Patient was advised to keep logs of on/off incidents.Patient was assisted with al feature to turn therapy on for patient, and the caller mentioned that there was a big difference when therapy on for patient.It was reviewed for patient to charge implant when ins was around 50% and monitor the ins, and was also redirected to follow up with the health care provider (hcp) regarding ins turning off.

• 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: 9291387
• MDR Text Key: 175462826
• Report Number: 3004209178-2019-21259
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Date Device Manufactured: 07/18/2019
• 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: 74 YR