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

Model Number 37702

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date inaccurate, only the year is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacturer's representative regarding an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that the patient had an ultrasound and since then they experienced intermittent shocking over the top of the battery- the patient described the sensation as a bee sting.The sensation seemed to be positional and they experienced the issue when their knees were up; sitting upright was ok but tilting to the left side and placing their hand on their chin caused the sensation.Prior to the call the representative turned stimulation off and back on and up to 5v and the patient wasn't feeling stimulation.The representative later programmed the patient to 4v and they were feeling stimulation.The patient moved into the troublesome position and they felt the stinging sensation for a short period.They turned the stimulation off and the patient moved in the same position and they reported not feeling the stinging.The impedances for group a1 was 520 ohms at 7.492 ma.At 0.7v impedances were between 643-848 ohms.It was reviewed that impedances looked normal.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer's representative.It was reported that they determined the issue could be related to the patient losing weight and the battery tilting on a nerve during positional changes.No further actions were taken- the patient was simply going to take it easy.No further complications reported.

• 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: 8391251
• MDR Text Key: 137860970
• Report Number: 3004209178-2019-04512
• 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
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2019
• Date Device Manufactured: 12/12/2011
• 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 Age: 63 YR