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

Model Number NEU_INS_STIMULATOR

Device Problem Unstable (1667)

Patient Problems Paresis (1998); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient has had a total of four implants.Of the four implants, two that were implanted on their right side both have flipped.The first implant that was implanted on their right side was done in 2018 and the patient stated that they had the second one implanted in 2019.Then they mentioned that they are unsure if the physician had just done a revision or implanted a new implantable neurostimulator (ins) in 2019 and they do not have an id card with the serial numbers on them.The patient stated that the implants have both flipped shortly after having them implanted.They have not had any falls or trauma and no weight gain or loss when the implants flipped.When they turn sideways, the ins "flips over like a saucer" and they have to "put it back down".The patient added that they are having trouble navigating through the email because their right hand is "kind of paralyzed" and their left hand does not work very well.They were redirected to their healthcare provider (hcp) to further address the issue.Refer to manufacturer report #3004209178-2021-00809 for related device.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11174338
• MDR Text Key: 227009956
• Report Number: 2182207-2021-00073
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• 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