MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Power Problem (3010)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.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 they were seeing power on reset (por) on the patient programmer.It was also reported to occur on the ins recharger (insr).The following por information was reviewed: reviewed meaning of por-power on reset.Therapy has stopped due to por.Patient reports por is on left ins.It was asked if the patient had any emi or had low charge.It sounds like the por might be possible due to low ins battery.Patient says it was 8th of a charge.Patient says she has been trying to charge the ins, it is charged now to 50%.Patient reports it is taking her longer to charge.No recent medical test or environmental exposure.Patient could not locate their patient programmer.Symptoms reported were patient having a lot of movement.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 manufacturer representative (rep) indicating that the troubleshooting done is unknown and results are unknown.The patient's ins was interrogated with the physician programmer and charged, no dates available.The cause is unknown.The issue is reported to be resolved.This information was confirmed by the physician.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7762365
• MDR Text Key: 117019964
• Report Number: 3004209178-2018-17671
• Device Sequence Number: 1
• Product Code: MHY
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 06/14/2011
• 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: 57 YR