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

Model Number 37602

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Dyskinesia (2363)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 7482a51, serial (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 3389s-40, lot# v234704, product type: lead.The main component of the system.Other relevant device(s) are: product id: 7482a51, serial/lot (b)(4), ubd: 11-may-2013, (b)(4); product id: 3389s-40, serial/lot #: v234704, ubd: 17-dec-2011, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of movement disorders.It was reported the patient got an oor message 3 days prior and on the day of the call.The rep confirmed the oor message with the clinician programmer.It was reported patient programmer use was infrequent and the patient did not report a change in therapy.Impedance on the programmed electrodes was: c0 841 ohms, c1 628, c2 4657, c3 1048, 0 & 1 831, 0 & 2 5115 ohms, 0 & 3 2182, 1 &2 4221, 1 & 3 3157, 2 & 3 8413 ohms.The patient was programmed on case and 1, therapy impedance was 784 ohms and 3.894 ma and ins battery voltage was 2.84 v.Electrode 2 was higher than normal.The rep called back later on the day of the call stating he had the patient do multiple different positions to try to reproduce the oor message.Electrical impedances were: c0: 858 ohms c1: 628 ohms c2: 751 ohms c3: 3427 ohms 01: 828 ohms 02: 5192 ohms 03: 3928 ohms 12: 4221 ohms 13: 3286 ohms 23: 8413 ohms the caller reported the patient was programmed with cv: 3.1 v/60/185 hz.Therapy impedances were 612 ohms and 784 ohms.It was reported the ins voltage seemed to have dropped.Estimated longevity performed: 3.1 v/60/185 hz.Therapy impedance: 612 ohms and 784 ohms.Six-hundred ten (610) ohms: eri: 2.59 years and eos: 2.84 years 780 ohms: eri: 3.14 years and eos: 3.39 years the caller reported the patient had multiple oor messages on the day of the call and had dyskinesia.It was unknown if the oor caused the dyskinesia.No further complications were reported or anticipated.

Manufacturer Narrative

Product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2009 explanted: product type extension product id (b)(4) lot# v234704 serial# implanted: explanted: product type lead product id (b)(4) lot# v234704 serial# implanted: explanted: product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional via the manufacturer representative stating the cause of the issue was not determined.Impedance tests were performed in various positions and at various time points and the patient was put on amantadine.It was reported the residual voltage increased after the dyskinesia stopped.

Manufacturer Narrative

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

• 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: 7487385
• MDR Text Key: 108001633
• Report Number: 3004209178-2018-10129
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

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: 05/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 06/04/2018
• Supplement Dates FDA Received: 05/15/2018; 06/05/2018
• Date Device Manufactured: 11/18/2017
• 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: 59 YR
• Patient Weight: 132