MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; SPINAL CORD STIMULATOR

Model Number SC-8216-70

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

Patient Problems Nerve Damage (1979); Visual Disturbances (2140); Numbness (2415)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model#: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that during an exercise movement, the patient experienced an extreme sharp and sudden pain in his back.Since that time, the patient reported symptoms of tingling sensation in his hands and wrists, bottom of both feet and throughout both legs.The patient was also experiencing periodically blurring eye sight vision and weakness in hands, and stated that he had noticed dropping items from his hand from time to time.The physician does not know if the patient's symptoms are device related, and does not know the cause of the symptoms.The patient was scheduled to undergo a myelogram; ct scans of the cervical, thoracic and lumbar as well as a ct brain to rule out cerebrospinal fluid leak.The patient was also scheduled to undergo an electromyogram (emg) and nerve conduction test, but the patient passed away due to cardiac arrest.Therefore, these tests were never performed and no further information can be provided.

• Brand Name: PRECISION SPECTRA®
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 5963894
• MDR Text Key: 55161886
• Report Number: 3006630150-2016-02673
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2012
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2010
• 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): Other
• Patient Age: 72 YR