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

Model Number 37601

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944); Positioning Problem (3009)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported the patient had a lead revision because the implanted lead was not providing optimal benefit/no efficacy.After trying since implant to get a good response through programming the physician decided to remove the lead and replace it.During the revision surgery they could not get the lead placed correctly and had to reposition it several times; due to the repositioning the physician felt the lead got crushed a bit and decided to use a new lead that is now implanted.It was noted they did not think there was a malfunction or defect with the lead; it was a positioning issue with the patient¿s anatomy and the amount of times it was repositioned.It was also reported some blood got into the sheath during the repositioning attempts.The patient was doing fine.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va0apd4, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4), product type: extension.Product id: 3708660, serial# (b)(4), product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# va0s545, product type: lead.(b)(4).

• 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: 4871358
• MDR Text Key: 6046020
• Report Number: 3004209178-2015-12320
• Device Sequence Number: 1
• Product Code: MHY
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2015
• Date Device Manufactured: 07/09/2013
• 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): Required Intervention