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

Model Number 37612

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 37751, serial# (b)(4), product type: recharger.Other relevant device(s) are: product id: 37751, serial/lot #: nka427348n.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 they were "having trouble about the dbs unit".It was clarified they meant the recharger had coupling issues even after replacing the ins recharger antenna.It was reported they were unable to obtain any coupling bars and saw the poor coupling screen.Repositioning the antenna, adjusting the antenna polarity disk, and using the antenna locate feature did not resolve the issue.The caller stated the implant site looked the same as it used to.The ins recharger was replaced.Additional information was received from a manufacturer representative (rep) reporting that the patient was in a hospital for a few days.The rep reported that the patient was at high settings and that there was a little issue with the recharging.The rep reported that they brought the patient back to surgery today and corrected the "potential misunderstanding, whatever." the rep reported the patient did not have their recharger with them.The rep reported that the battery could go out because they had been in the hospital for 3 days.The rep reported the healthcare provider (hcp) gave the patient a charger out of inventory.Additional information was received: it was reported that the rep said to refer to the hcp in terms of the hospitalization.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: 7584617
• MDR Text Key: 110570612
• Report Number: 3004209178-2018-13027
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2018
• Date Device Manufactured: 03/17/2018
• 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): Hospitalization
• Patient Age: 67 YR