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

Model Number 37612

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# unknown, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient implanted with a neurostimulator.It was reported that recently the patient had a sudden return of symptoms, so their system was checked in which it was found that there was a lead break.It is expected that a new lead will be placed on the tuesday following the report date.The cause of the issue is unknown with the patient currently in good condition.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

No new information was received.

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturing representative (rep) clarified this was a lead issue, found by checking the extension wire and testing cables.

Manufacturer Narrative

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

Event Description

No additional information was received.

Manufacturer Narrative

Analysis of the lead (lot no.Unknown) found that all of the conductors were broken 3.1 cm from the proximal end.Conclusion code updated.Result code updated.Method code updated.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7502502
• MDR Text Key: 107851412
• Report Number: 3007566237-2018-01401
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/07/2019

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: 08/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 05/10/2018; 06/12/2018; 10/29/2018; 01/04/2019
• Supplement Dates FDA Received: 05/31/2018; 06/27/2018; 10/30/2018; 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2016
• 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
• Patient Age: 40 YR