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

Model Number 37601

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Bradycardia (1751); Fainting (1847); Fall (1848); Low Blood Pressure/ Hypotension (1914); Weakness (2145); Complaint, Ill-Defined (2331)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson's disease and movement disorders.It was reported the hcp was admitting the patient due to acute onset of weakness and near fainting episode in which the patient fell on their nose.The caller noted the patient was hypotensive and had signs of initial bradycardia.The caller stated according to the patient's son, the ins had a history of low battery and the ins was scheduled to be replaced within the following weeks.The patient's son noted that in the past, when the ins neared depletion the patient started to feel "off" and that was what they were experiencing at the time of the call.The caller stated ekgs conducted were clear and did not have background noise from the ins which they would expect so the caller believed the ins may already be depleted and need to be replaced sooner than the scheduled date.The caller confirmed the issues the patient was experiencing were likely due to the ins depleting.The caller stated the patient did not have a patient programmer with them.The caller noted the patient was fine prior to the day of the call.No further complications were reported or 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: 7553798
• MDR Text Key: 109562253
• Report Number: 3004209178-2018-12151
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

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: 12/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 05/30/2018
• Date Device Manufactured: 07/06/2017
• 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): Hospitalization
• Patient Age: 88 YR