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

Model Number 37603

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Product id: 3387s-40, lot# v814474, implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: lead.Product id: 3387s-40, lot# v646607, implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: v814474, ubd: 18(b)(6) 2014, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: v646607, ubd: (b)(6) 2013, udi#: (b)(4).Explant dates of leads is an approximate.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) for dystonia and movement disorders.It was reported that the patient is having a difficult time getting a correct answer from anyone and is looking for information.They are reporting that the patient had a short and electrical discharge in sept/oct 2017 and it was discovered in (b)(6) 2018 and the patient turned the therapy off (b)(6) 2018 and dystonia came back and don't have use of her hands or feet.Caller states the leads failed/malfunctioned and lead was replaced on (b)(6) 2018 and they turned the device back on but the doctor didn't want to put the settings where it used to be.Caller reports the doctor refused to put the voltage back on to where it was because of the resistance being high.Caller states they were told my a specialist that the resistance was within range and the voltage needs to be increased and healthcare provider is not willing to do anything.Caller says the therapy worked flawlessly for 7 years.No further complications were reported or anticipated with this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7489014
• MDR Text Key: 107438792
• Report Number: 3004209178-2018-10179
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

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: 09/28/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/04/2018
• Date Device Manufactured: 04/13/2016
• 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
• Patient Age: 30 YR