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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Ambient Noise Problem (2877)

Patient Problems Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient felt a "really weird sensation.A wonky feeling" right after they got a diagnostic ultrasound.The patient stated that the sensation lasted for 5 minutes at most.The patient compared the sensation to the "electrical rush" they felt in the past when they turned therapy off and then back on, or when they turned therapy settings "way up." they stated that transducer was placed directly over their implantable neurostimulator (ins) because the diagnostic ultrasound was for a routine breast cancer screening.They added that a few days later they felt pain around the ins area.They felt like the ins moved a little bit, "like the soft tissue around it got torn away from the battery." it hurt a little bit worse when they move their arm up."right around the sutures" was where they were feeling the most pain.However, at the time of the call, the patient stated that they were feeling just a little bit better and felt a little less pain.They were redirected to their healthcare provider.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12933891
• MDR Text Key: 281747723
• Report Number: 3004209178-2021-18009
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Date Device Manufactured: 03/15/2019
• 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
• Patient Sex: Female