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

Model Number 37702

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Overheating of Device (1437)

Patient Problems Therapeutic Effects, Unexpected (2099); Vomiting (2144); Burning Sensation (2146); Dizziness (2194); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a260, lot# va13mzs018, product type: lead.Product id: 977a260, lot# va13mzs019, product type: lead.

Event Description

The manufacturing representative reported that there were elevated impedances 5,000 - 6,000 ohms after the new implantable neurostimulator (ins) was placed.The patient used the device for a few days after surgery and had good coverage.The patient was hospitalized for gastroenteritis at which time her stimulation was off and the patient had a cat scan.The patient attempted to turn stimulation on but they reached 7 volts and the patient wasn't feeling stimulation in areas of pain and only felt a burning/pressure sensation slightly about pocket site and towards their spine.The patient had attempted to program other electrodes but wasn't able to elicit any stimulation.The patient was unaware of any impedance issues prior to replacement.The patient had been vomiting severely.The patient also mentioned an occurrence of patient not falling to the floor but rather patient stood up from recliner and became dizzy and slumped back into their chair.The patient had no other falls or trauma.The change in therapy was not related to positional movement.The patient did not feel stimulation while standing or sitting.The patient was programmed on the date of report was 2+, 5+, 10+, 11-, 12-, 360 pulse width, and 115 rate.Electrode impedance test was performed at 3.0 volts, 1.5 volts, and 0.7 volts and all showed electrodes high out of range.The manufacturing representative first saw high impedances at the time of replacement.Imaging was performed and comparing the imaging from (b)(6) 2016 which showed that both leads had moved.The patient was going to be scheduled for a lead revision.Relevant medical history included: non-malignant pain.

Event Description

Additional information received from the manufacturer representative reported that the patient had a lead revision on (b)(6) 2016 due to the leads migrating out of the epidural space.The patient had stated that the migration was due to a gastro-intestinal virus and vomiting and they were getting no therapy and were not feeling anything.

Manufacturer Narrative

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

• 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
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5517877
• MDR Text Key: 40926234
• Report Number: 3004209178-2016-05123
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Date Device Manufactured: 04/13/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00051 YR