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

Model Number 37603

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Alteration In Body Temperature (2682)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2015, product type: extension, product id: 37603.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 28-aug-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacture representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins) for parkinson's dual and movement disorders.The rep called in for longevity calculations; 1.7 v 60 sec 130 hz 3652o hms.The technical services specialist (tss) did not confirm 24/7 usage but provided >10 year estimate regardless as that still holds true.High therapy impedances were noted.The rep indicated using the tablet to test this, further mentioning they tested at 3 v though therapy impedance will measure at the settings assigned for this program.On 2019-apr-10, additional information was received from a manufacturer representative (rep) stating the cause of the high therapy impedances was not determined.The rep also noted that they did not attempt to perform an impedance measurement with the clinician programmer believing the results to be accurate.The impedance value obtained at 3.0 v were within normal range thereby reinforcing the belief that the results obtained by the tablet were true and accurate.For the purpose of the impedance measurement, the rep elected to use the automatic ramping capability contained within the activa application.As the ins in question was not at eri, the implanting physician elected to take no action.The patient and spouse shared with the rep that they had observed that the skin immediately overlying the left electrode wire in the scalp was warm to touch whereas the skin immediately adjacent to the wires was normal.The patient denied discomfort of other painful/unusual events outside of that which was described by the patient and spouse.The rep shared this information with the implanting physician who acknowledged the report.There was no resolution to the high therapy impedance as the consent for this procedure was for replacement of the right side ins which had reached eri.No further patient complications were reported/ anticipated as a result of 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: 8582564
• MDR Text Key: 144851219
• Report Number: 3004209178-2019-08936
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2019

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: 01/28/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/06/2019
• Date Device Manufactured: 08/06/2015
• 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: 57 YR
• Patient Weight: 75