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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pocket Erosion (2013); Complaint, Ill-Defined (2331); Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_ptm_prog, product type: programmer, patient.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 deep brain stimulation therapy indications.It was reported that the patient had possible erosion at the pocket site and was in bad shape.They were falling over and collapsing.Location of symptoms was at the pocket and on one side of the body.It was unclear when the issues started.They further reported the external remote hasn't worked in a long time.The ins appeared to be eroding per caller and the patient saw a physician within the last 10 days and indicated the pocket was fine, no issues.It was unknown if the issues were related to ins.No further complications were reported or anticipated with this event.Additional information received from the healthcare provider (hcp) stated a battery replacement took place.This answer was in response to the hcp being asked when the erosion, patient in bad shape, and falling was first noticed, cause of the issues mentioned, what was done to resolve these, and if the issue was resolved.No further complications were anticipated.

• 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: 8623971
• MDR Text Key: 145508951
• Report Number: 3004209178-2019-09896
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2019
• Date Device Manufactured: 06/08/2018
• 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): Required Intervention