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

Model Number 37603

Device Problems Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Tingling (2171)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387s-40, lot# va01ga6, product type: lead.Product id: 3387s-40, lot# v792258, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: va01ga6, ubd: (b)(6) 2014, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: v792258, ubd: (b)(6) 2014, udi#: (b)(4).All codes apply to both leads.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for an unknown dbs therapy.It was reported that the patient was feeling tingling in their right arm and leg when sitting or standing, they didn¿t¿ feel it if they were laying and were slightly elevated.Caller said impedance showed 0 & 1 at 63 ohms, the rest were at 1000-2000 ohms.Caller didn¿t have impedance value with them.Patient was programmed c and -1, impedance was good and patient didn¿t have any negative symptoms.Caller said the patient¿s lead broke through the skin and hcp debrided the area yesterday, area between the cap and connection.Caller said they noticed it (b)(6), wound issue.Impedance check in (b)(6) 2017, retesting impedance in different head positions.Caller to consult with surgeon.There were no further complications reported.

• 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: 7534721
• MDR Text Key: 108941576
• Report Number: 3004209178-2018-11559
• 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: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

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: 04/14/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 05/22/2018
• Date Device Manufactured: 10/21/2016
• 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): Other
• Patient Age: 78 YR