MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37702

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.Caller reports patient was seen 2 months ago, and ins was not functioning at that time.Caller reports patient is having increased pain.Caller reports patient has been trying to get a physician to check patient's device.Additional information was received from the patient.The patient clarified the issue: their implant doesn't work- they've changed batteries and everything and it's not connecting to the piece that¿s implanted in their back.The one time they did get it connected, they couldn't shut it off.Then it wouldn't connect.The patient noted they have extra pain going down their legs, back and butt.They are trying to get it fixed.Their back is very sore when touched.It hurts so bad in that area and swelling.They think its infected and they have a limp.They cannot find anyone that works with the gadget anymore.No report of use of antibiotics.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12290059
• MDR Text Key: 265482353
• Report Number: 3004209178-2021-12037
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Date Device Manufactured: 01/25/2016
• 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): Other
• Patient Age: 53 YR
• Patient Weight: 46