MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

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

Patient Problems Wound Dehiscence (1154); Complaint, Ill-Defined (2331)

Event Date 04/18/2014

Event Type  Injury  

Event Description

It was reported the left stimulator was visible and the wound was open.After the surgery a crust formed on the wound and when it fell off there was an open wound in which the stimulator was visible.The patient did not contact their physician at the time.The patient was hospitalized and the stimulator was explanted and not replaced.The event was related to the procedure and the outcome was ongoing.If additional information is received on outcome, a follow-up report will be sent.Refer to manufacturer report # 3004209178-2015-04537 it was unknown which stimulator was explanted and replaced.

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 338902836, lot# b9993681k, implanted: (b)(6) 2000, product type: lead.Product id: 338902836, lot# b9992982k, implanted: (b)(6) 2000, product type: lead.(b)(4).

Event Description

Additional information reported the stimulator and lead have been explanted without replacement at this time.A future system implant was planned.The event is resolved without sequelae.

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.

Manufacturer Narrative

Final analysis of the stimulator revealed no anomaly found.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the study center changed the clinical diagnosis from open wound, left stimulator visible to implant site erosion.The device diagnosis had been removed.Device diagnosis was entered as stimulator perforation.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4591605
• MDR Text Key: 5468408
• Report Number: 3004209178-2015-04539
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• 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; Required Intervention
• Patient Age: 00077 YR