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

Model Number 37603

Device Problems Shipping Damage or Problem (1570); Battery Problem (2885)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturing representative (rep) regarding an event with no patient involvement.It was reported that the battery voltage of the ins's was low (3.08 v) at implant.The devices were replaced with new products whose voltages were above 3.10 v.No patient symptoms or further complications were reported as a result of this event.Refer to manufacturer report #3007566237-2018-03732 for details pertaining to the related reportable event.

Event Description

No additional information was received.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

2018-12-07 (b)(4): information was received from a manufacturing representative (rep) regarding a patient with an im plantable neurostimulator (ins) for parkinson's disease.It was reported that the battery voltage of the ins's was low (3.08 v) at implant.The devices were replaced with new products whose voltages were above 3.10 v.No patient symptoms or further complications were reported as a result of this event.2019-01-25 (b)(4): no additional information was received.

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 MN 00777 1200
• MDR Report Key: 8204066
• MDR Text Key: 131711038
• Report Number: 3007566237-2018-03733
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/25/2019; 04/09/2019
• Supplement Dates FDA Received: 01/25/2019; 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1