MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97702

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

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Discomfort (2330); Malaise (2359); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 08/14/2015

Event Type  Injury  

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.

Event Description

A healthcare provider (hcp) in a foreign clinical study reported that a patient called because they did not feel good.They said their scar was painful and uncomfortable.They were red and inflamed.The patient went to their general hcp and they were given antibiotics.They went in the next day, (b)(6)2015, and the hcp looked at it and sent the patient to the urgency medical to check blood.The scan was abnormal and they had fluid coming out of their breast, too.The patient was hospitalized on (b)(6) 2015 and received antibiotics via an iv and it was noted that everything was fine.The event was noted to be unlikely related to the device or therapy and not related to the procedure and were related to the implantable neurostimulator (ins) pocket.It was resolved without sequelae on 2015 (b)(6).No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the event was possibly related to the device or therapy and not related to the implant procedure.

Manufacturer Narrative

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

Event Description

Additional information was received from healthcare professional of a foreign clinical study.It was reported that device was changed long ago thus the real cause of the event was not known.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6687459
• MDR Text Key: 79092838
• Report Number: 3004209178-2017-14257
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/06/2017; 07/17/2017
• Supplement Dates FDA Received: 07/14/2017; 07/19/2017
• Date Device Manufactured: 11/25/2013
• 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