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

Model Number 37602

Device Problems Shipping Damage or Problem (1570); Connection Problem (2900); Impedance Problem (2950)

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

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: neu_set_screw, serial# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for parkinson's disease.It was reported that during the replacement of the ins on both sides, the screw of the #2 electrode of the ins on the left side, which was newly unpacked, could not be tightened and the impedance of the #2 electrode was abnormal.The impedance was checked several times after disconnection and reconnections, however no improvement was seen.A new screw was unpacked and used, and the procedure continued as the impedance was normal.The event was considered resolved.This was suspected to be an out of box issue.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a rep indicated the cause of the screw not tightening was not known.

Manufacturer Narrative

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

Event Description

Additional information received from a rep indicated the ins was originally considered to have an anomaly on circuit #2.

Manufacturer Narrative

Analysis of the ins (serial no.(b)(4)) was performed, despite there being no original allegation on the device.The ins was returned with 4 set screws, and no anomaly was found with the set screws, however the repair analyst noted that the problem set screw was likely not returned.Correspondence with the manufacturing representative indicated the location of this set screw was unknown.The ins was found to have no malfunction.Product analysis #241045567:analysis information -- 2019-04-05 13:34:34 cst pli# 10 product id# 37602 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.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 00777
• MDR Report Key: 8370861
• MDR Text Key: 139195232
• Report Number: 3004209178-2019-04008
• 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,Followup
• Report Date: 06/19/2019

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: 03/14/2020
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/27/2019; 04/05/2019; 06/17/2019
• Supplement Dates FDA Received: 03/05/2019; 04/12/2019; 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1