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 Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported, the patient¿s left device system was removed in (b)(6) 2010 due to an infection.Preoperatively, prophylactic antibiotics were prescribed according to protocol.The wounds were irrigated with copious amounts of bacitracin and betadine intraoperatively.Postoperatively, antibiotics were administered via peripherally inserted central catheter (picc) line.The infection resolved following implantation.It was noted, there were plans for bilateral re-implantation, but no date was provided.The patient¿s right system was removed due to an infection as well and it was unclear if information regarding the antibiotics were in relation to the patient¿s left or right device systems; follow was requested for clarification.Refer to mfr report # 3004209178-2015 for the event regarding the patient¿s right system.

Manufacturer Narrative

Product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2010 (b)(6); product type extension product id 3391s-40, lot# v257753, implanted: 2010 (b)(6), explanted: 2010 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2010, product type: extension.Product id 3391s-40, lot# v257753, implanted: (b)(6) 2010, explanted: (b)(6) 2010, product type: lead.

Event Description

Additional information received reported that the following information was pertaining to the patient's right side device and not the left side.Preoperatively, prophylactic antibiotics were prescribed according to protocol.The wounds were irrigated with copious amounts of bacitracin and betadine intraoperatively.Postoperatively, antibiotics were administered via peripherally inserted central catheter (picc) line.

• 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: 4889016
• MDR Text Key: 6263880
• Report Number: 3004209178-2015-12721
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Date Device Manufactured: 02/16/2010
• 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: 00068 YR