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

Model Number 7426

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

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

It was reported the patient had been having a lot of problems with falling and they were in a wheelchair.A patient injury was reported.The reporter stated they thought the patient fell 37 times before they had surgery for their back in (b)(6) 2010.The patient continued to fall since the surgery in 2010.The reporter stated they read something about deep brain stimulation and heard there was a recall that covered a lead so they wondered if the patient¿s implantable neurostimulator (ins) that was removed was part of the recall.The patient¿s ins was replaced on (b)(4) 2014.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, the event will be updated.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v165128, implanted: (b)(4) 2008, product type: lead.Product id: 7482a40, serial# (b)(4), product type: extension.Product id: 3387s-40, lot# v165128, implanted: (b)(6) 2008, product type: lead.Product id: neu_unknown_prog, product type: programmer, physician.(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: 4484557
• MDR Text Key: 5504516
• Report Number: 3004209178-2015-01751
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2015
• Date Device Manufactured: 09/08/2008
• 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: 00071 YR