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

Model Number 37602

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Pain (1994); Irritability (2421); Electric Shock (2554)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that the patient (pt) was in pain for the last six months after they had a brain tumor and they had a procedure where their face and brain stim were operated on to get tumor out.The therapy was working well prior to about 6 months ago.Now, they were irritable and the pain was so much they could jump off a bridge.The patient said they took methadone to manage their pain.Patient initially said their settings on their patient programmer had not changed.Later, they said they may have changed their settings accidently. during the call patient services assisted patient in checking therapy: therapy showed on, okay at 3.3 v.Pt said first said they could not go any higher with their settings.The patient said they had increased stimulation to 3.4 v and that seemed to take care of the pain in their face but they clarified weren't able to keep stimulation at that level and therefore they weren't able to increase to 3.4 v because they would get this awful pain in their head if they did.They would feel shocking/jolting sensations on their lead.They only had one group.They worried that their implanted neurostimulator battery was low because they didn't feel like it had been working at the same level that it usually did because typically when they used the deep brain stimulation and the methadone medication they took for pain they did well but they just hadn't been doing well.Ins voltage was at 2.84 v and battery was ok.Patient was redirected to their healthcare provider.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

• 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: 14458446
• MDR Text Key: 292506034
• Report Number: 3004209178-2022-06480
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Date Device Manufactured: 05/29/2014
• 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 Age: 60 YR
• Patient Sex: Female