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

Model Number 97713

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bronchitis (1752); Sepsis (2067); Seroma (2069); Electric Shock (2554)

Event Date 06/24/2016

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

Information was received from a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient was in the hospital for sepsis on (b)(6) 2016.It was reported that the hospital stay for sepsis was related to the device.

Manufacturer Narrative

New date ((b)(6) 2016) is the updated date for the initial report when the sepsis was reported.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the sepsis was discovered to not be related to the device on (b)(6) 2016.It was reported by the consumer that she went to the hospital, was diagnosed with sepsis and the stated that it might have been related to the battery replacement surgery.A ct scan was performed with results showing seroma at the battery site and the patient was in the hospital for five days getting antibiotics.The issue was not resolved and the patient was alive with no injury at the time of the report.On (b)(6) 2016, a healthcare professional (hcp) reported that he was not convinced that the ins caused the sepsis and the patient had bronchitis at the time of the initial report.The hcp also reported that wound did not look infected but just appeared it was slow to heal.In conclusion, the patient received medicine for bronchitis.

Event Description

Additional information was received.Patient reported they were hospitalized for 5 days and indicated the sepsis was from their nerve stimulator shocking them from inside their body.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• 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: 5976429
• MDR Text Key: 55578718
• Report Number: 3004209178-2016-19657
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2016

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: 08/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/11/2016
• Supplement Dates FDA Received: 10/10/2016; 11/02/2016; 09/25/2017
• Date Device Manufactured: 08/06/2015
• 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; Other
• Patient Age: 58 YR