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

Model Number SC-1132

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

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/27/2019

Event Type  Injury  

Event Description

A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.

Manufacturer Narrative

The returned ipg was analyzed, passed all required tests performed and exhibited normal device characteristics.The complaint was not confirmed.

Event Description

A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.

Manufacturer Narrative

Additional information was received that the physician assessed the patient never felt pain relief and implied the patient may have psychological issues that could have impacted the pain outcomes.The patient is doing well postoperatively.

Event Description

A report was received that the patient experienced a burning pain when stimulation was on or off and she was dissatisfied with the stimulation.The patient underwent an ipg explant procedure.

• Brand Name: PRECISION SPECTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8809347
• MDR Text Key: 151654873
• Report Number: 3006630150-2019-03711
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 19584525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention