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

Model Number 37702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Edema (1820); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099)

Event Date 06/12/2016

Event Type  Injury  

Event Description

A consumer reported that after the implant procedure, the patient symptoms of leg pain, swollen feet, and foot pus were not improved.The patient's health care provider (hcp) told them that there was no effect and no way to improve the symptoms.The patient was currently in treatment in a local hospital and they had been given a pain killer.The patient did not have a 50 percent or more reduction in symptoms.The cause of the event was unknown and it was unknown if any troubleshooting was done.The patient wanted their symptoms to improve.The patient's indication for use is lower limb ischemic pain.

Event Description

Additional information reported the patient was implanted with spinal cord stimulation (scs) due to lower limb ischemic pain.It was unknown if the hospitalization was related to the patient's device or therapy, unknown if diagnostics or troubleshooting was done, unknown if actions or interventions were taken or planned, and unknown if the patient was receiving effective therapy.The patient's outcome also was unknown.

Event Description

The manufacturer representative reported the patient experienced pedal edema and foot suppuration (in addition to the leg pain) after the spinal cord stimulation implant on (b)(6) 2016.The patient was hospitalized and under observation at a local hospital after receiving anesthetics.If the state of the patient deteriorated, the patient will visit the doctor at the hospital in which the implantation was performed.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5952275
• MDR Text Key: 54772826
• Report Number: 3004209178-2016-18959
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Date Device Manufactured: 08/14/2015
• 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): Hospitalization
• Patient Age: 86 YR