MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT; PERIPHERAL NERVE STIMULATOR

Model Number	9600-9244-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fluid Discharge (2686); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient reportedly experienced drainage from the lead exit site on their right ankle.A picture was provided, taken the day the drainage was first reported, and appears to show skin irritation (i.E., redness) where the edge of the adhesive or non-adhesive portion of the waterproof bandage presumably was, as well as what may be dried surgical glue and/or discharge at the lead exit site.The photo was sent to the patient's physician and antibiotics were prescribed for treatment of the irritation.The following day, the patient reported continued drainage, as well as swelling in both of their ankles.Photos were provided, taken two days after the initial report of drainage, and appear to show swelling of the right ankle, increased skin irritation (i.E., redness) and broken skin surrounding the lead exit site.Three days after the drainage was initially reported, the patient was seen by their physician for evaluation of the issue and both leads were removed prior to the planned end of treatment date.The patient was reportedly sent from their physician's office to the emergency room (er) for further evaluation of the issue.The er physician reportedly suspected a streptococcal infection; note that there was no report of a culture to confirm the suspected infection.The patient received intravenous (iv) antibiotics at the er as well as additional prescribed oral antibiotics for continued treatment of the issue.The patient has a known diagnosis of complex regional pain syndrome (crps), which may cause changes in swelling and/or skin color of the affected limb.Therefore, it is possible the patient's pre-existing medical condition(s) unrelated to sprint may have caused or contributed to the issues reported in this complaint.Per follow-up with a representative in contact with the patient, the patient reportedly has a history of reactions to adhesives prior to being implanted with sprint.Given that the patterns of irritation experienced appear to coincide with the area that would have presumably been covered by the waterproof bandage, it is possible that the issues reported in this complaint may have been caused or exacerbated by an increased sensitivity to adhesive system components (e.G., the bandage).Given that the patient did not report irritation or suspected infection at their contralateral lead exit site, it is likely that site-specific factors (e.G., maintenance of the lead exit site and/or bandage) contributed to the issues reported in this complaint.It is also possible that the patient may have been at an increased risk for skin irritation and/or potential infection developing at the lead exit site given that the skin around the lead exit was reportedly shaved (rather than clipped) prior to the lead placement procedure, contrary to recommendations in the sprint clinician instructions for use.Per an update provided by a representative in contact with the patient, the patient's condition was reported to be improving and the lead exit site was mostly healed, but the issues had not fully resolved at the time of complaint investigation.If additional information regarding resolution of the issue becomes available, this investigation will be updated.
Event or Problem Description
The patient reportedly experienced drainage from the lead exit site on their ankle along with swelling, skin irritation (i.E., redness) where the edge of the adhesive or non-adhesive portion of the waterproof bandage presumably was, and broken skin surrounding the lead exist site.Antibiotics were prescribed for treatment of the irritation.The patient was seen by their physician for evaluation of the issue and both leads were removed prior to the planned end of treatment date.The patient was sent from their physician's office to the emergency room (er) for further evaluation of the issue.There he received intravenous (iv) antibiotics as well as additional prescribed oral antibiotics for continued treatment of the issue.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste. 500; cleveland, OH 44122
• MDR Report Key: 17429851
• Report Number: 3011035812-2023-00013
• Device Sequence Number: 7153455
• Product Code: NHI
• UDI-Device Identifier: 00854001007588
• UDI-Public: (01)00854001007588(17)240225(10)68424290
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: 9600-9244-60
• Device Lot Number: 68424290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male