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); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Dyskinesia (2363)

Event Date 05/17/2018

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 who was implanted with an implantable neuro stimulator (ins) for parkinson's dual and movement disorders.It was reported that the patient's implant battery suddenly shut off and the patient experienced a return of dyskinesia symptoms.Patient stated that they thought the ins charge level was too low and stimulation turned off.Patient was able to use the ins recharger (insr) and verified stimulation was off.Patient was unable to turn stimulation back on as they did not have the patient programmer (pp).The patient was currently charging the ins (25 to 49% currently charged), but stimulation needed to be turned back on.The patient was never given a patient programmer (pp) from the health care professional (hcp)'s office, and it was reviewed that the hcp needed to order a pp for the patient.Patient stated they had a pp manual but did not have the pp.A message was sent to the field staff to assist the patient in turning the ins back on for the patient.Patient thought having all 8 coupling boxes on the insr on the insr meant the ins was fully charged, further stating that they charged the morning of the report but after reviewing the charging screen vs the coupling boxes, and patient was aware the ins was currently fully depleted.Patient stated they would continue to charge the ins.No further patient complications were reported/ anticipated as a result of this event.

• 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: 7530115
• MDR Text Key: 108998062
• Report Number: 3004209178-2018-11390
• 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: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Date Device Manufactured: 03/16/2018
• 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 Age: 64 YR