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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

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 healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient's ins turned off a lot of times a day in the last week.The patient is able to turn the ins back on with the programmer.It was stated that there was no therapy lost.Recharging is normal and there was no error code shown.The patient's hcp checked the impedance and found no issues.The issue was not yet resolved at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturing representative.It was stated that the patient has not reported any more occurrences of the ins turning off.The ins data was analyzed again, and no anomalies were found.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider (hcp) via a man.It was reported that the patient remembers stimulation turning off on (b)(6), at 2pm and (b)(6) at 9am.The loss of stimulation was stated to be unpleasant for the patient.The ins data was analyzed and it was determined that there were no entries of therapy loss.It was noted that there was activity performed by the patient programmer or recharger on the days noted by the patient.There were no anomalies seen in the ins data.Based off of the data analysis it was reported that the on/off events were likely triggered by the programmer, and that the patient may have problems handling the device.The exact cause was not determined.The only other action taken will be to possibly look at the ins data one more time.The issue was not yet resolved.

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7767193
• MDR Text Key: 116866041
• Report Number: 3007566237-2018-02359
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• 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,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• 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: 01/17/2015
• 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