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

Model Number 7426

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient had experienced a shocking sensation and had a lead replacement because of this.It was unknown when this had occurred.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-40, lot# j0428351v, implanted: (b)(6) 2004, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 3389s-40, lot# v452133, implanted: (b)(6) 2010, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(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: 4617036
• MDR Text Key: 5595037
• Report Number: 3004209178-2015-05041
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2008
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2015
• Date Device Manufactured: 08/09/2006
• 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: 00072 YR