MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1110-02

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred seven months ago from the date the manufacturer was made aware.

Event Description

It was reported that the patients battery location on the right side is a bit too caudal into the gluteal margin and feels like she is sitting on a rock when sitting.The ipg has achieved end-stage battery life status.Repeated and difficulty charging does not provide appropriated benefit with stimulation.It was also noted that the patient was having random spasms into the lower back.The patient was prescribed with medications and received epidural steroid injections with variable benefit.

Event Description

It was reported that the patients battery location on the right side is a bit too caudal into the gluteal margin and feels like she is sitting on a rock when sitting.The ipg has achieved end-stage battery life status.Repeated and difficulty charging does not provide appropriated benefit with stimulation.It was also noted that the patient was having random spasms into the lower back.The patient was prescribed with medications and received epidural steroid injections with variable benefit.Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned per hospital policy.

• Brand Name: PRECISION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12724538
• MDR Text Key: 279266278
• Report Number: 3006630150-2021-06095
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2013
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 14457567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 87 KG