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

Model Number 37702

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that patient had their ins replaced along with wires because it "malfunctioned" and patient indicated they had a lot of scar tissues around it.Patient further clarified that they started having problems and indicated it was hitting their stomach and made them feel like they were doing sit ups and they felt really sick.Patient reported health care provider thought the leads were too high.It was reported that when the patient had surgery to replace the ins and the leads that was when the scar tissue was discovered.No further complications reported and/or anticipated at this time.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9219596
• MDR Text Key: 163190277
• Report Number: 3004209178-2019-20140
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Date Device Manufactured: 04/18/2012
• 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: 36 YR