MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Intermittent Continuity (1121); Migration or Expulsion of Device (1395); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

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).It was reported that the patient checked the ins because it felt like it was going on and off.Caller reported out of regulation (oor) message on the patient programmer.Caller reports on the 8840 seeing a message similar to the oor 64 message.Impedances taken were normal.It was reviewed use of high therapy parameters can lead to high current draw resulting in oor.Consider checking impedance on programmed electrodes.3-c+ 80pw 185 3.05 1159 ohms 2.680 battery voltage shows 2.77 ok.No out of range impedances.The oor condition was not present at the conclusion of the call.Caller took impedances in different positions of patient head and no change in impedances.After stim was turned back on and reread impedances battery voltage went to 2.80v.Caller reports the patient was underweight at implant and has since gained some weight possible shifting the ins as it doesn't feel completely flat as it did.Caller will request patient note if the "on/off" feeling happens again to note what the patient was doing.Symptoms reported were tremor ret urn.It was reported to be a gradual change in therapy/symptoms.Worsened over two weeks.Additional notes included electrode c3 1215 and therapy 1182 2.628.No further complications were reported or anticipated.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7602569
• MDR Text Key: 111992509
• Report Number: 3007566237-2018-01786
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• 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: 45 YR