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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Break (1069); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3389s-40, lot#: va1h8ba, implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 10-apr-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that after routine check of the patient's neurostimulator with the patient programmer (pp), the battery was displaying an elective replacement indicator (eri) message.Patient was implanted on (b)(6) 2018 and this early depletion led to further analysis.No environmental/external or patient factors led to issue.Impedance check was performed today.Patients impedances showed short circuits between contact 0 & 1 and between 2 & 3.Impedances on both bipolar where 33.The doctor turned the voltage down to 0 on the left side to minimize the loss of current, and the right side was still on.The doctor would be relaying the information to the neurosurgeon to possibly schedule a revision surgery of the lead.Patient had not expressed any symptom changes.The issue was not resolved at the time of the report.No surgical intervention had been planned/occurred yet.No further patient complications were reported/anticipated as a result of this event.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# va1h8ba implanted: (b)(6)2018 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep indicating that the cause for the short circuit seems to stem from a damaged lead, but surgical intervention would determine if this is the case.A lead revision has been scheduled for (b)(6), both the lead and battery will be replaced.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# va1h8ba, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type lead.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep) indicating that both the lead and battery were replaced on (b)(6) 2018, and once replaced the impedances cleared up.The rep indicated that the lead and ins will not be returned for analysis.When the lead was explanted, there was visible damage to it.

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: 7601436
• MDR Text Key: 111893925
• Report Number: 3004209178-2018-13427
• Device Sequence Number: 1
• Product Code: MHY
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/14/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR