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

Model Number 37702

Device Problems High impedance (1291); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3777-60, serial/lot #: (b)(4), ubd: 02-jun-2019, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient's stimulation pattern changed.It was also noted that the patient felt 'electric shocks' throughout their body on 2 separate occasions on the same night during a thunderstorm.Examination of the diary showed zero stimulation usage for this time period.The rep ran an impedance test and found that the 8-15 lead had >10,000 ohms on all electrodes.Lead revision was not planned as reprogramming with the other lead covered all pain areas.No further complications were reported.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7872126
• MDR Text Key: 123422442
• Report Number: 3004209178-2018-20525
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 09/13/2018
• Date Device Manufactured: 05/04/2015
• 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