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); Delayed Charge Time (2586)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

A health care provider (hcp) reported via a manufacturer representative that the patient's implantable neurostimulator (ins) was found to be off when the patient arrived for a routine review with the hcp.The hcp was able to turn the ins back on.No causes were reported when the hcp was questioned.No diagnostics or troubleshooting was done.No impedance data or recharge history was recorded.No surgical intervention was taken and the patient was alive with no injury.The issue was resolved at the time of this report.The patient's indication for use is dystonia.

Manufacturer Narrative

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 received from a health care provider (hcp) via a manufacturer representative reported the patient experienced a worsening of their symptom control.The implantable neurostimulator (ins) was found to be off during a routine follow up appointment.The reason for the ins being off was not determined.No error messages were displayed when the ins was turned back on.

Manufacturer Narrative

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 received from a health care provider (hcp) via a manufacturer representative reported the patient did not experience any symptoms.The patient did not have a programmer and when the hcp checked the ins it was okay.The patient charged the ins every day since it took three months to fully charge the ins.The patient's recharger indicated the ins was not turned off so the patient kept charging until the ins was fully charged.After the ins was fully charged, recharging only took five minutes.

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.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6373434
• MDR Text Key: 68979443
• Report Number: 3004209178-2017-04933
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/13/2017; 03/13/2017
• Supplement Dates FDA Received: 03/06/2017; 03/14/2017; 10/02/2017; 10/02/2017
• Date Device Manufactured: 03/11/2016
• 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: 36 YR