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

Model Number 37612

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinsons dual and movement disorders.It was reported the patient cannot get the ins 100% recharged.The patient stated they had been charging three times a week for one hour, and some times an hour and a half.The patient sometimes got all eight bars and other times they didn't.It was also said that when they start charging they were almost half full and when they were finished charging they were almost half full.The patient said their ins was 3/4 full and 1/4 charging.The insr was full.They went over charging and had no boxes.It was advised the patient rotate their antenna and with that the patient got all eight bars.Then the patient lost the bars.It was advised to reposition the antenna again and with that the patient got all boxes back.It was told to the patient to recharge for a longer period of time, it was believed the patient wasn't charging long enough and also to make sure they had 6-8 bars filled in.The patient also reported the device didn't feel like the other one and that it made them tired.The patient was going to the doctor on tuesday.The doctor upped their voltage from 2.3/2.4 to 2.6 volts.This was said to make the patient feel different then the other.It was advised to maybe be decreased.No further complications were reported as a result of this event.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider.The recharging and stimulation issues remain unresolved and the cause remains unknown.

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 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: 6671640
• MDR Text Key: 78582390
• Report Number: 3004209178-2017-13847
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• Date Device Manufactured: 03/20/2017
• 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: 76 YR
• Patient Weight: 37