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

Model Number 7426

Device Problems Break (1069); Unintended Collision (1429)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that in 2005, the patient fell and tore both leads.A revision was done in (b)(6) and the other was done sometime in (b)(6) 2005.The patient had a wound revision during one of the surgeries and the leads were repositioned.Refer to manufacturer report #6000032-2015-00117.

Manufacturer Narrative

Concomitant products: product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 7426, serial # (b)(4), implanted: (b)(6) 2003, product type implantable neurostimulator; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2003, product type implantable neurostimulator.(b)(4).

• Brand Name: SOLETRA
• 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: 4866043
• MDR Text Key: 5863075
• Report Number: 3004209178-2015-12135
• 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: Consumer,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/03/2015

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: 11/28/2005
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/24/2015
• Date Device Manufactured: 06/11/2004
• 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: 00055 YR