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

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)

Event Date 09/16/2011

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that ever since their first implantable neurostimulator (ins) was implanted, they have noticed that their walking and fine motor skills (eating and writing) were affected depending on the active group.The patient explained that certain groups allow them to walk safely, but they are unable write or eat when those groups are active.The patient noted that certain groups allow for them to eat and write, but they are unable to walk safely when those groups are active.They have always noticed an uncomfortable "jolt" whenever they changed amplitude, which they confirmed had also occurred ever since their first ins was implanted.The patient was unclear as to whether this happened when increasing amplitude, decreasing amplitude, or both.The "jolt" sensation has been "gentler" since the percept pc was implanted and asked if the "jolt" sensation changed when they got the percept pc because the amplitude is measured in ma rather than volts.The patient was redirected to their healthcare provider for further discussion. the patient asked if their current leads have any pulse width limitations compared to sensight leads.No allegations were made regarding the le ads.Refer to manufacturer report #3004209178-2021-12250 and #3004209178-2021-12251 for related devices.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12308172
• MDR Text Key: 266046800
• Report Number: 3004209178-2021-12252
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: 08/11/2021

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: 03/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/11/2021
• Date Device Manufactured: 09/22/2015
• 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: 69 YR