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

Model Number 37601

Device Problems Device Difficult to Program or Calibrate (1496); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

The implantable neurostimulator (ins) battery was found to be at it's normal end of life.The telemetry and output were okay.The longevity estimate was 8.36 months to eri and 11.36 months to eos.According to the trace report the ins reached eri in 8.87 months and eos in 11.53 months.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 the patient had been symptomatic again with a return of symptoms and a panic attack.The patient use deep brain stimulation (dbs) for obsessive compulsive disorder (ocd).The hcp suspected the implantable neurostimulator (ins) was depleted or nearing depletion based on the patient's parameters, a longevity calculation, and their return of symptoms.The symptoms suddenly returned in (b)(6) 2015.On (b)(6) 2015, the patient met with their hcp after having a panic attack.The hcp checked the ins, saw the settings and that the ins was on so they figured that was the output being given to the patient.The hcp decided to adjust the patient's medication and not the ins.The ins was working at the appointment on (b)(6) 2015.The ins went dead without the patient being aware so they had a "pretty rough two weeks." the patient thought the ins depleted sometime after (b)(6) 2015.A longevity calculated estimated the ins to reach end of service (eos) after 11.3 months.An eos message was displayed when the ins was interrogated on (b)(6) 2015.The hcp had decided to do some programming since the old settings did not seem to be helping the patient anymore.The hcp wanted to move contact one to contact zero, but they could not since the ins was at eos.The ins was off/disabled and no longer providing therapy.The ins was programmed to 7v, 90 usec, and 135 hz with a therapy impedance of 850 ohms on one side and 7v, 90 usec, and 135 hz with a therapy impedance of 870 ohms on the other side.There were no indications of shorts in the circuits used for programming.The hcp planned to coordinate an ins replacement surgery.The ins was replaced two days later.The patient did not say they were upset with the ins longevity, but they had stated it was less than a year.Additional information was received from a health care provider (hcp).It was reported that the device was removed due to the implantable neurostimulator (ins) failing.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5836468
• MDR Text Key: 50838400
• Report Number: 3004209178-2016-15253
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• PMA/PMN Number: H050003
• 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
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR