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

Model Number 37702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Tingling (2171); Malaise (2359); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient implanted with an implantable neurostimulator (ins) for cervical/neck. It was reported that the patient wanted to have his ins removed because it was not helping him and the patient thought the ins was making him sick. The patient was sick all the time; his stomach was always upset. The patient had been to healthcare professionals and they could not find what was wrong with him, nobody knew. The patient was to follow-up with a healthcare professional, but did not have a managing healthcare professional. The issues began years prior to (b)(6) 2016, the patient didn¿t know the exact year. Additional information received from the patient reported that when they would turn stimulation on, it would go into their arms instead of where the pain was, and it would be more of a tingling feeling. The patient stated that the sickness feeling hasn¿t yet been resolved. It was noted that the patient visited their healthcare provider (hcp) and an ultrasound was performed. The ultrasound revealed a grayish white gallbladder. The patient was told that it was bad and didn¿t look normal, and that they needed it taken out. The patient¿s gallbladder was removed in (b)(6) 2016. It was noted that the patient had previous ultrasounds where the hcp was unable to find anything. It was reported that the patient¿s sickness feeling never went away and that they thought it was because of the gallbladder, but they were still sick 24/7. The patient stated that the sickness feeling would even be present when eating and wouldn¿t allow them to feel full. It was further reported that the patient¿s stimulation was off all the time as it wasn¿t helping them. The patient stated that the stimulation was ¿just like electricity¿ going down the arms. The patient was to follow up with a hcp and was provided with physician listings.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6180834
• MDR Text Key: 102065730
• Report Number: 3004209178-2016-26617
• 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: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/28/2010
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/13/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial