MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the outer casing on a titan anchor was partially separated from the titanium inner when attempting to replace a lead, and was explanted on (b)(6) 2014.The patient denied any trauma or auto accident that may have caused this situation.The cause of the issue was undetermined.At the time of the report the patient was alive with no injury.Unrelated can¿t implant lead event captured in (b)(4).Unrelated high impedances event captured in (b)(4).

Manufacturer Narrative

Concomitant medical products: product id neu_unknown, serial# unknown, implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: unknown; product id 377860, lot# v006694, implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: lead; product id 3708120, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: extension; product id 37743, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient.(b)(4).

Event Description

All further follow up information regarding this event will be reported under manufacturer regulatory report # 3004209178-2014-17405.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 4101914
• MDR Text Key: 4756123
• Report Number: 3004209178-2014-17371
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• Date Device Manufactured: 03/12/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0500-2010
• Patient Sequence Number: 1